RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCE

BANGLORE, KARNATAKA

ANNEXURE II

Proforma for Registration of Subjects for Dissertation.

1

Name and address of candidate

Arunkrishnan.V.R

Alva’s College Of Physiotherapy.

Moodbidri-

574227.

2

Name of institution

Alva’s College Of Physiotherapy.

Moodbidri.

Karnataka-

574227.

3

Course of study and subject

Master of physiotherapy

(Musculoskeletal disorders and sports physiotherapy)

4

Date of admission to the course

02-08-2010

5

Title of study

Effectiveness of splinting as compared with neural mobilization in reducing pain and improving functional ability of hand in carpal tunnel syndrome- Experimental study.

6. BRIEF RESUME OF INTENDED WORK

CARPAL TUNNEL SYNDROME (CTS), or compression neuropathy of the median nerve at the wrist, is a cause of pain, numbness, and tingling in the upper extremities and an increasingly recognized cause of work disability. Carpal tunnel syndrome constitutes a major part of the occupational upper-extremity disorders and is associated with considerable health care and indemnity costs. (1,2,7)

It is commonly seen in patient of 30 to 60 years old and the syndrome is approximately three times more common in women than in men. A recent study shows that CTS occurs at a rate of 3.46 cases per thousand persons.(2,7) High prevalence rates have been reported in persons who perform certain repetitive wrist motions, but the significance of this relationship continues to be challenged. Although 30 percent of frequent computer users complain of hand paresthesias, only 10 percent meet clinical criteria for carpal tunnel syndrome.(2,7)CTS also cited as one of the most common neuropathies in sports such as cycling, football, golf, hockey, lacrosse, rock climbing, weight lifting, wheel chair athletics and wrestling.(18,19,20)

CAUSES AND CONTRIBUTING FACTORS

Researchers have identified a variety of factors that may cause or contribute to the development of carpal tunnel syndrome. These factors include the presence of commonly noted co-occurring health conditions are non-inflammatory synovial fibrosis, metabolic syndrome, diabetes, thyroid disorders, rheumatoid arthritis, pregnancy, and menopause. And engagement in an occupation or activity that involves repetitive use of the hand, and the presence of a range of personal or physical factors that may indicate a predisposition to carpal tunnel syndrome. (2, 7)

The carpal tunnel is a narrow passage way on the palm side of the wrist. Surrounded by bones and ligaments, the carpal tunnel houses and protects the tendons of the hand and the median nerve, which controls sensations to the thumb and fingers. When the median nerve becomes pinched or compressed due to swelling or irritation in adjacent tissues or tendons, the result can be pain, numbness, hand weakness, and in extreme cases, loss of hand function. Cases of bilateral carpal tunnel syndrome have been reported, but typically only one hand is affected .Carpal tunnel syndrome is rare in children, it usually occurs only in adults.(2, 7) The symptoms are numbness, burning, or tingling in the fingers and palm of the hand Pain in the wrist, palm, or forearm, decreased grip strength, weakness in the thumb, difficulty in distinguishing between hot and cold. Symptoms may cause waking during the night with the urge to “shake out” the hand or wrist. Symptoms may occur with activities that require prolonged grasping or flexing of the wrist, untreated carpal tunnel syndrome can progress to persistent numbness and permanent loss of hand function. In severe and chronic cases, irreversible muscle damage or atrophy may occur. Complete sensory loss in the hand has also been reported. (2, 7)

Different therapies available in treatment of carpal tunnel syndrome include splinting, ultrasound and laser therapy, massage, neural mobilization, carpal bone mobilization, tendon gliding exercise, corticosteroid therapy, anti-inflammatory therapy, carpal tunnel releasing surgery.(1,2,3,4,5)

KEYWORDS USED: CARPALTUNNEL SYNDROME; CONSERVATIVE TREATMENT; NERVE GLIDING EXERCISE; TENDON GLIDING EXERCISE;ULTRASOUND;

SPLINTING

6.1 NEED OF STUDY

Many of the literature review reveals that conservative management is very beneficial in the treatment of carpal tunnel syndrome to reduce pain and improve the functional ability of the patients. So the need of the study is to investigate and compare the therapeutic effectiveness of 2 different combinations in the conservative management of carpal tunnel syndrome.

The combinations include ultrasound and splinting with tendon gliding exercise when compared with ultrasound and neural mobilization with tendon gliding exercise to reduce pain and improve functional ability of hand in carpal tunnel syndrome patients.(2,4,7,6,8,15)

.

6.2 OBJECTIVES OF STUDY

1) To assess the effect of ultrasound and splinting along with tendon gliding exercise in reducing pain and improving functional ability of hand in CTS.

2) To assess the effect of ultrasound and neural mobilization along with tendon gliding exercise in reducing pain and improving functional ability of hand in CTS.

3) To compare the effect of ultrasound and splinting along with tendon gliding exercise versus ultrasound and neural mobilization along with tendon gliding exercise in reducing pain and improving functional ability of hand in CTS.

HYPOTHESIS

NULL HYPOTHESIS

H01 - Ultrasound and splinting along with tendon gliding exercise is not significantly

effective in reducing pain and improving functional ability of hand in CTS.

H02 - Ultrasound and Neural mobilization along with tendon gliding exercise is not

significantly effective in reducing pain and improving functional ability of hand

in CTS.

H03 - Ultrasound and splinting along with tendon gliding exercise and Ultrasound and

neural mobilization along with tendon gliding exercise are equally effective in

reducing pain and improving functional ability of hand in CTS.

EXPERIMENTAL HYPOTHESIS

H1- Ultrasound and splinting along with tendon gliding exercise is significantly

effective in reducing pain and improving functional ability of hand in CTS.

H2- Ultrasound and neural mobilization along with tendon gliding exercise is

significantly effective in reducing pain and improving functional ability of hand

in CTS.

H3- Ultrasound and neural mobilization along with tendon gliding exercise is more

effective than ultrasound and splinting along with tendon gliding exercise in

reducing pain and improving functional ability of hand in CTS.

6.3 REVIEW OF LITERATURE

Yildiz, Necmettin. Atalay, Nilgun Simsir etal (2011) have done a study titled as Comparison of ultrasound and ketoprofen phonophoresis in the treatment of carpal tunnel syndrome. This study was a prospective, randomized, controlled, double-blinded clinical trial with follow-up at 8 weeks. 51 patients with evidence of mild or moderate CTS were included in the study. They were randomly assigned to one of three groups; group 1 received sham US and splinting, group 2 received US and splinting, and group 3 received ketoprofen phonophoresis and splinting. According to the studies they reveals that Ultrasound and splinting is more effective along with ketoprofen phonophoresis in the treatment of carpal tunnel syndrome.13

Ayse N.Bardak et al (2009) have done a study titled as Evaluation of the clinical efficacy of the conservative treatment in the management of carpel tunnel syndrome, a randomized single blinded trail. In this study they took 111 patients who were diagnosed as CTS, patients was randomized in to 3 groups; Group(1) treated with standard conservative treatment (SCT) consist of splint being applied to neutral position and local steroid injection betamethason. Group (2) treated with SCT and tendon and nerve gliding exercise. Group(3) tendon and nerve gliding exercise only. The results shows that SCT combines with tendon and nerve gliding exercise is effective than SCT alone.10

Finch E.et al (2008)in their book Physical rehabilitation outcome measures commented that Visual Analogue Scale (VAS) directly measures the intensity of pain and therefore has high content validity and has high test-retest reliability.9

Senthil Nathan Sambandam et al(2008) have done a study titled

as Critical analysis of outcome measures used in the assessment of carpal tunnel

syndrome. In this study, they critically analyzed the conceptual framework, validity,

reliability, responsiveness and appropriateness of some of the commonly used 6 CTS

outcome measures. It reveals that Boston Carpal Tunnel Syndrome Questionnaire

(BCTQ), Michigan Hand Outcome Questionnaire (MHQ) and Patient Evaluation

Measure (PEM) have comprehensive frame works, good validity, reliability and

responsiveness both in the hands of the developers, as well as independent

researchers. It clearly shows Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)

have good validity, and reliability. The scales were highly reproducible and internally consistent in the hands of the developer, with a reproducibility of r=0.91 for symptom severity scale and r=0.93 for functional status scale IC (Cronbach’s alpha) of 0.89 for the symptom severity scale and 0.91 for the functional status scale.5

David J.Magee et al (2008) in their book Orthopaedic physical

assessment commented reliability and validity of Tinel’s sign, Phalen’s test ,hand

dynamometer and Pinch meter .Tinel’s sign reliability intrarater K= 0.80, interrator

K= 0.77, K=0.81, interrator K=.051, validity P>.11. Phalen’s test reliability intrarater

K=0.53, interrater K=0.65, validity P< .05. Jamar hand dynamometer validity

stronger result with wrist 15 or 30 degrees of extension with neutral radio ulnar

deviation with or without extension P= .021-.004 . Pinch strength reliability

K=0.76, specificity Tester 1- 88%,Tester2- 78% ,sensitivity Tester1-72%,Tester2-

70%.11

Carolyn Kisner et al (2007) in their book Therapeutic exercise commented that conservative managements including Joint mobilisation, tendon gliding exercise, median nerve mobilization are minimizing or eliminating the causative factor in carpal tunnel syndrome.6

Syed Mozaffor Ahamed et al (2007) have done a study titled as A review of carpal tunnel syndrome. This study they mentioned the etiology of carpal tunnel syndrome and diagnosing methods and they also reveals that Conservative managements like ultrasound therapy, therapeutic splinting, exercise and job modifications are effective in the management of carpal tunnel syndrome.7

O. Baysal, Z. Altay et al (2006) have done a study titled as comparison of three conservative treatment protocols in carpal tunnel syndrome. In this study they took 28 female patients and investigate and compare the effectiveness of 3 different combinations in conservative management of CTS, the combinations include tendon and nerve gliding exercise with splinting, ultrasound combination with splinting, ultrasound and splinting with tendon and nerve gliding exercise. The result of long term satisfaction questionnaire, grip power measurement reveals that symptomatic improvement in the group treated with ultrasound therapy and splinting along with tendon and nerve gliding exercise is effective immediately and 8 weeks after the treatment.4

Amir H Bakhtiary et al(2004) have done a study titled as

Ultrasound and laser therapy in the treatment of carpal tunnel syndrome. They took

90 peoples, 50 patients CTS confirmed by EMG, were allocated in 2 experimental

group. One group received ultrasound therapy (1 MHz, 1.0 W/cm2, pulse 1:4, 15

min/session),other group received low level laser therapy (9 joules,830nm infrared

laser at five points). End of the study they reveals that ultrasound therapy is more

effective than low level laser treatment in patient with mild to moderate carpal tunnel

syndrome.15

Dimitrios Kostopoulos et al (2004) have done study titled as

Treatment of carpal tunnel syndrome: a review of the non-surgical approaches with

emphasis in neural mobilization. In this study will reviews the evidence regarding

neuro dynamic testing and neural mobilization of the median nerve as a treatment

approach to carpal tunnel syndrome.8

Walker. WC et al (2000) have done a study titled as Neutral

wrist splinting in carpal tunnel syndrome: a comparison of night-only versus full-time

wear instructions, randomized clinical trial. In this study they took 21 patients with 6-

week follow-up. This study provides added scientific evidence to support the efficacy

of neutral wrist splints in CTS and suggests that physiologic improvement is best with

full-time splint wear.14

Isam Atroshi et al (1999) have done a study titled as a prevalence of CTS in general population. In this study they took 3000 subjects was randomly selected, out of 354 reported symptoms on clinical examination. Based on their study they reveals that 1in5 symptomatic subjects would expect as carpal tunnel syndrome.1

David S. Butler et al (1999) in their book mobilization of the nervous system clearly shows the nervous system clearly shows the anatomy, physiology, and neuro biomechanics of nervous system. And it also reveals the advantage of mobilization of the nervous system in the CTS.21

7. MATERIALS AND METHODOLOGY

7.1 SOURCE OF DATA

· Alva’s outpatient department, Moodbidri.

· Alva’s outpatient department, Karkala.

· Alva’s Physical Education College, Moodbidri.

· Referred cases from various hospitals of Dakshina Karnataka.

7.2.METHOD OF COLLECTION OF DATA

Research design - Experimental design (Comparative study).

Sample design -Convenient sampling.

SAMPLE SIZE

Total sample- 40.

Group A- 20 patients-Ultrasound and splinting in combination with tendon gliding exercise.

Group B-20 patients - Ultrasound and neural mobilization in combination with tendon gliding exercise.

7.3 SELECTION CRITERIA

INCLUSION CRITERIA

· Age-30 year to 60 year.

· Gender- male and female.

· Willingness to participate.

· Positive clinical test (phalen’s/Tinels).

· Symptoms lasting for at least 2 weeks.

· Patients with VAS score of at least 4 out of 11 point number scale.

EXCLUSION CRITERIA

· Secondary entrapment neuropathy.

· Required regular analgesic and anti inflammatory drugs.

· Psychosocial problems.

· Pregnancy.

· Hyperthyroidism.

· Post wrist fracture conditions.

· Unwillingness to participate in the study.

· Infectious disease.

7.4 PROCEDURE

40 subject who fulfill the selection criteria shall be selected by convenient sampling and an informed consent will be obtained from them. These subjects will be distributed into two groups A and B respectively (20 in each group).

The pre and post test physical examination includes Tinel’s test, Phalen’s test.11Pain measurement by VAS scale9 and hand grip strength is measured with hand held dynamometer and pinch strength measured with a standard dynamometer between tips of the thumb and fingers.11Symptoms and functional status were evaluated by symptom-severity scale and functional status scale5 (BCTQ).The Symptom-severity scale has eleven questions and the functional status scale has eight questions.

Group A (experimental group) subjects will receive ultrasound therapy to the palmar carpal tunnel area (15 minutes daily, frequency of 1 MHz, intensity 1.0 watt/cm2, pulsed mode 1:4 with transducer of 5cm2 with acquasonic gel as couplant)4,7and advise the patient to wear wrist splint all night and during day for 3 weeks.4,7,10With tendon gliding exercise by fingers we place in 5 discrete position.4,7,16

Group B (experimental group) subjects will receive ultrasound therapy to the palmar carpal tunnel area (15 minutes daily, frequency of 1 MHz, intensity 1.0 watt/cm2,pulsed mode 1:4 with transducer of 5cm2 with acquasonic gel as couplant)4,7. And median nerve mobilization exercise by putting the hand and wrist in 6 different position. During this exercise the neck and shoulder will be in neutral position, each position will be maintained for 7 seconds, exercise applies 3 sections daily 5 repetitions and exercise treatment continuous for 3 weeks.10

At the end of each and every week intervention subjects shall undergo post test evaluation of VAS, hand grip and pinch grip measurement, and symptoms and functional status measurement. After 3 weeks, follow up to compare the effectiveness of two treatment protocols.

And the results obtained by the data collection shall be taken for statistical analysis to compare the effectiveness of intervention between the 2 groups.

MATERIALS NEEDED FOR STUDY

· Symptoms and functional status evaluation chart sheets (BCTQ).

· Hand strength and pinch strength dynamometer.

· Ultra sound machine- 1 MHz.

· Acquasonic gel for ultrasound treatment.

· Resting splint-for maintaining hand in neutral position.

· Pencil, paper and recording sheets and other stationery items.

· VAS pain rating chart-sheets.

STATISTICAL METHOD

· The inter group comparison will be done using Independent ‘t’-Test.

· The intra group comparison will be done using Paired ‘t’-Test.

7.5 Does this study require investigations or interventions to be conducted on

patients or other humans or animals?

Yes, the study requires intervention to be done on patients.

7.6 Does this study have ethical clearance?

Yes, Permission is obtained from ethical committee of the college to carry out this

study. The copy is attached (Annexure-II).

8. LIST OF REFERENCES

1. Isam Atroshi, MD, Christina Gummesson, MS Ragnar Johnsson, MD, PhD, Ewald Ornstein, MD. Prevalence of Carpal Tunnel Syndrome in a General Population. Journal of American Medical Association. July 14, 1999—Vol 281.

2. Anthony J. Viera. Management of Carpal Tunnel Syndrome. Journal of American Academy of Family Physicians. 2003:68:265-72,279-80.

3. Sheila Kitchen. Electrotherapy: Evidence Based Practice. edition 11th;. Churchill Livingstone. 2002. p. 221.

4. O. BAYSAL.Z. ALTAY. C. OZCAN. Comparison of three conservative treatment protocols in carpal tunnel syndrome. Blackwell Publishing Ltd Int Journal of Clinical Practice, July 2006, 60, 7, 820–828.

5. Senthil Nathan Sambandam, P. Priyanka, Arif Gul. Critical analysis of outcome. measures used in the assessment of carpal tunnel syndrome; Journal of international orthopaedics . 2008 August; 32(4): 497–504.

6. Carolyn Kisner, Lynn Allen Colby: Therapeutic Exercise 5th edition; Jaypee publishers.2007.p.375-376.

7. Syedmozafor Ahamed, A.K Mohamad salek, Moniruzzamn Khan. Review of carpal tunnel syndrome. Journal of Chikkago Medical college Teachers association.2007;18(2);32-36.

8. Dimitrios Kostopoulos. Treatment of carpal tunnel syndrome: a review of the non-surgical approaches with emphasis in neural mobilization ; Journal of body work and movement therapies;20048,2-8.

9. Finch E. Brooks D. Startford P.W. Mayo N.E. Physical Rehabilitation Outcome Measures. A Guide to Enhanced Clinical Decision Making. 2nd edition. Baltimore: Wiliams & Wilkins; p. 244-245.

10. Ayse N Badak. Mehmet AP. Belhin Erhan. Evaluation of clinical efficacy of conservative treatment in the management of Carpal tunnel syndrome; Journal of Advanced therapy (2009);26(1).

11. David J.Magee :Orthopaedic physical assessment 5th edition ;Elsevier publications 2008. P 468-470.

12. A. Tal-Akabi, A. Rushton. An investigation to compare the effectiveness of carpal bone mobilization and neurodynamic mobilization as methods of treatment for carpal tunnel syndrome. Journal of Manual Therapy (2000) 5(4), 214±222.

13. Yildiz, Necmettin. Atalay, Nilgun Simsir. Pamukkale University Medical School, Department of Physical Medicine and Rehabilitation. Comparison of ultrasound and ketoprofen phonophoresis in the treatment of carpal tunnel syndrome. Journal of Back & Musculoskeletal Rehabilitation. 24(1):39-47, 2011.

14. Walker, W C. Metzler, M. Cifu, D X. Swartz, Z. Neutral wrist splinting in carpal tunnel syndrome a comparison of night-only versus full-time wear instructions; Journal of Archives of physical medicine and rehabilitation; 81(4):424-9, 2000.

15. Amir H Bakhtiary1 and Ali Rashidy-Pour. Ultrasound and laser therapy in the treatment of carpal tunnel syndrome; Journal of Australian physiotherapy 2004 ,vol 50.

16. Totten PA, Hunter JM. Therapeutic techniques to enhance nerve gliding in thoracic outlet syndrome and carpal tunnel syndrome; Hand Clin 1991; 7: 505–20.

17. Randolph M.Kesler M D, Darlene Hertling ; Management of common musculoskeletal disorders 3rd edition ;Lippincott Williams and Wilkins publications 1996. P 265,266,268.

18. Toth C, McNeil S, Feasby T. Peripheral nervous system injuries in sport and recreation: a systemic review; Sports Med.2005:35:717-738.

19. Krivickas LS, Wilbourn AJ. Peripheral nerve injuries in athletes: a case series of over 200 injuries. Semin Neurol.2000:20:225-232.

20. Boninger, Michael L, Robertson, Rick N, Wolff, Michael , Cooper, Rory A; Upper limb nerve entrapments in elite wheel chair racers; American Journal of Physical Medicine & Rehabilitation. 75(3):170-176, May/June 1996.

21. David S.Butler, Mark A.Jones; Mobilization of the Nervous system; Churchill Livingstone publishers. 1999 p-58-66,122,220,221.

22. Pamela k. Levangie, Cynthia C. Norkin; Joint structure and Function; 4th edition. Jaypee publishers. p-319-320.

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