Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05466162
Other study ID # HamnaS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 21, 2021
Est. completion date August 2022

Study information

Verified date July 2022
Source Dow University of Health Sciences
Contact Hamna Syed, DPT
Phone +923043257150
Email hamnasyyd6@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this experimental study is to determine the effect of soft tissue massage along with mobilization technique on intensity of pain by visual analog scale and functional status by using Jamar hand-held dynamometer, Pinch Gauge and Boston Scale for carpal tunnel syndrome questionnaire in Carpal tunnel syndrome patients. It is being conducted on patients with Carpal tunnel syndrome at Sindh Institute of Physical Medicine and Rehabilitation, Karachi and Neurological outpatient department of Dr. Ruth K. M. Pfau, Civil Hospital Karachi among Sixty participants with mild and moderate severity of Carpal Tunnel Syndrome will be randomly allocated in two groups after initial screening by a consultant physiatrist according to CTS-6 scale. Written informed consent will be taken from each participant. Group A will be treated with soft tissue massage (Medenci hand massage technique) along with joint (radiocarpal and inter-carpal) and median nerve mobilization slider technique while group B will be treated with joint (radiocarpal and inter-carpal) and median nerve mobilization slider technique only. Participant will be evaluated by visual analog pain scale, Boston scale of carpal tunnel syndrome, dynamometer and -pinch gauge, Center for Epidemiologic Studies Depression Scale and Pain Anxiety Symptoms Scale on day 1 and last treatment session.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date August 2022
Est. primary completion date August 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Consultant Physiatrist will be diagnosed patients of carpal tunnel syndrome on electro diagnostic test i.e. Nerve Conduction Studies. - Mild and moderate severity of Carpal tunnel syndrome. - Age: 18-50 years - Both gender patients with unilateral involvement of the hand Exclusion Criteria: - Exclusion Criteria: - In electro diagnostic test, either motor or sensory deficit in the ulnar nerve and radial nerve. - Other Neurological problems ( cervical myelopathy, motor neuron disease like amyotrophic lateral sclerosis - Neoplasm around the affected arm - Presence of other musculoskeletal problems of upper quadrant (for example: rheumatoid arthritis or fibromyalgia, cervical radiculopathy) - Any recent history of trauma of upper extremity on affected side

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Soft tissue mobilization
Soft tissue massage therapy includes Madenci hand massage technique initiate with 30-second (sec) effleurage, followed by 60- sec friction, 30-sec petrissage, 30-sec shaking, and ends with 30-sec effleurage. It takes totally of 3 min Passive mobilizations of the wrist : radio-carpal joint in flexion and extension, maintained hand in traction. (30 oscillations, 5 sets and 30 secs interval between each step) Inter-carpal horizontal flexion and extension. (30 oscillations, 5 sets and 30 secs interval between each step) . Nerve Mobilization treatment( Slider technique) followed by Shoulder will be in depression, abduction on gleno-humeral joint and rotated externally, forearm will be in a supination, elbow flexion and wrist, elbow extension and wrist, thumb, and finger flexion Treatment sessions: 3set, 10 reps, with hold for 10 secs
Joint and nerve mobilization
Passive mobilizations of the wrist : radio-carpal joint in flexion and extension, maintained hand in traction. (30 oscillations, 5 sets and 30 secs interval between each step) Inter-carpal horizontal flexion and extension. (30 oscillations, 5 sets and 30 secs interval between each step) Nerve Mobilization treatment( Slider technique) followed by Shoulder will be in depression, abduction on gleno-humeral joint and rotated externally, forearm will be in a supination, elbow flexion and wrist, elbow extension and wrist, thumb, and finger flexion Treatment sessions: 3set, 10 reps, with hold for 10 secs.

Locations

Country Name City State
Pakistan Sindh Institute of Physical Medicine and Rehabilitation Karachi Sindh

Sponsors (1)

Lead Sponsor Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

References & Publications (24)

Aboonq MS. Pathophysiology of carpal tunnel syndrome. Neurosciences (Riyadh). 2015 Jan;20(1):4-9. Review. — View Citation

Chung VC, Wong SY, Kung K, Zee CY, Leung WN, Chong KC, Wong M, Wong C, Griffiths SM. Electroacupuncture and wrist splinting for carpal tunnel syndrome: a randomised trial. Hong Kong Med J. 2017 Jun;23 Suppl 2(3):28-31. — View Citation

de Krom MC, Knipschild PG, Kester AD, Thijs CT, Boekkooi PF, Spaans F. Carpal tunnel syndrome: prevalence in the general population. J Clin Epidemiol. 1992 Apr;45(4):373-6. — View Citation

De-la-Llave-Rincon AI, Ortega-Santiago R, Ambite-Quesada S, Gil-Crujera A, Puentedura EJ, Valenza MC, Fernández-de-las-Peñas C. Response of pain intensity to soft tissue mobilization and neurodynamic technique: a series of 18 patients with chronic carpal tunnel syndrome. J Manipulative Physiol Ther. 2012 Jul;35(6):420-7. doi: 10.1016/j.jmpt.2012.06.002. Epub 2012 Jul 31. — View Citation

Dinarvand V, Abdollahi I, Raeissadat SA, Mohseni Bandpei MA, Babaee M, Talimkhani A. The Effect of Scaphoid and Hamate Mobilization on Treatment of Patients with Carpal Tunnel Syndrome. Anesth Pain Med. 2017 Oct 23;7(5):e14621. doi: 10.5812/aapm.14621. eCollection 2017 Oct. — View Citation

Eftekharsadat B, Babaei-Ghazani A, Habibzadeh A. The Efficacy of 100 and 300 mg Gabapentin in the Treatment of Carpal Tunnel Syndrome. Iran J Pharm Res. 2015 Fall;14(4):1275-80. — View Citation

Fernández-de-Las-Peñas C, Cleland J, Palacios-Ceña M, Fuensalida-Novo S, Pareja JA, Alonso-Blanco C. The Effectiveness of Manual Therapy Versus Surgery on Self-reported Function, Cervical Range of Motion, and Pinch Grip Force in Carpal Tunnel Syndrome: A Randomized Clinical Trial. J Orthop Sports Phys Ther. 2017 Mar;47(3):151-161. doi: 10.2519/jospt.2017.7090. Epub 2017 Feb 3. — View Citation

Geler Külcü D, Bursali C, Aktas I, Bozkurt Alp S, Ünlü Özkan F, Akpinar P. Kinesiotaping as an alternative treatment method for carpal tunnel syndrome. Turk J Med Sci. 2016 Jun 23;46(4):1042-9. doi: 10.3906/sag-1503-4. — View Citation

Huisstede BM, Hoogvliet P, Franke TP, Randsdorp MS, Koes BW. Carpal Tunnel Syndrome: Effectiveness of Physical Therapy and Electrophysical Modalities. An Updated Systematic Review of Randomized Controlled Trials. Arch Phys Med Rehabil. 2018 Aug;99(8):1623-1634.e23. doi: 10.1016/j.apmr.2017.08.482. Epub 2017 Sep 20. — View Citation

Iftikhar S, Javed MA, Kasuri MN. Frequency of Metabolic Syndrome and Its Components in Patients with Carpal Tunnel Syndrome. J Coll Physicians Surg Pak. 2016 May;26(5):380-3. doi: 2319. — View Citation

Khosrawi S, Emadi M, Mahmoodian AE. Effectiveness of splinting and splinting plus local steroid injection in severe carpal tunnel syndrome: A Randomized control clinical trial. Adv Biomed Res. 2016 Feb 8;5:16. doi: 10.4103/2277-9175.175902. eCollection 2016. — View Citation

Klimek L, Bergmann KC, Biedermann T, Bousquet J, Hellings P, Jung K, Merk H, Olze H, Schlenter W, Stock P, Ring J, Wagenmann M, Wehrmann W, Mösges R, Pfaar O. Visual analogue scales (VAS): Measuring instruments for the documentation of symptoms and therapy monitoring in cases of allergic rhinitis in everyday health care: Position Paper of the German Society of Allergology (AeDA) and the German Society of Allergy and Clinical Immunology (DGAKI), ENT Section, in collaboration with the working group on Clinical Immunology, Allergology and Environmental Medicine of the German Society of Otorhinolaryngology, Head and Neck Surgery (DGHNOKHC). Allergo J Int. 2017;26(1):16-24. doi: 10.1007/s40629-016-0006-7. Epub 2017 Jan 19. — View Citation

Klokkari D, Mamais I. Effectiveness of surgical versus conservative treatment for carpal tunnel syndrome: A systematic review, meta-analysis and qualitative analysis. Hong Kong Physiother J. 2018 Dec;38(2):91-114. doi: 10.1142/S1013702518500087. Epub 2018 Jul 2. — View Citation

Koca I, Boyaci A, Tutoglu A, Ucar M, Kocaturk O. Assessment of the effectiveness of interferential current therapy and TENS in the management of carpal tunnel syndrome: a randomized controlled study. Rheumatol Int. 2014 Dec;34(12):1639-45. doi: 10.1007/s00296-014-3005-3. Epub 2014 Apr 12. — View Citation

Lewis KJ, Coppieters MW, Ross L, Hughes I, Vicenzino B, Schmid AB. Group education, night splinting and home exercises reduce conversion to surgery for carpal tunnel syndrome: a multicentre randomised trial. J Physiother. 2020 Apr;66(2):97-104. doi: 10.1016/j.jphys.2020.03.007. Epub 2020 Apr 11. — View Citation

Lindstrom-Hazel D, Kratt A, Bix L. Interrater reliability of students using hand and pinch dynamometers. Am J Occup Ther. 2009 Mar-Apr;63(2):193-7. — View Citation

Madenci E, Altindag O, Koca I, Yilmaz M, Gur A. Reliability and efficacy of the new massage technique on the treatment in the patients with carpal tunnel syndrome. Rheumatol Int. 2012 Oct;32(10):3171-9. Epub 2011 Sep 28. — View Citation

Nataraj R, Evans PJ, Seitz WH Jr, Li ZM. Effects of carpal tunnel syndrome on reach-to-pinch performance. PLoS One. 2014 Mar 14;9(3):e92063. doi: 10.1371/journal.pone.0092063. eCollection 2014. — View Citation

Newington L, Harris EC, Walker-Bone K. Carpal tunnel syndrome and work. Best Pract Res Clin Rheumatol. 2015 Jun;29(3):440-53. doi: 10.1016/j.berh.2015.04.026. Epub 2015 May 27. Review. — View Citation

Papanicolaou GD, McCabe SJ, Firrell J. The prevalence and characteristics of nerve compression symptoms in the general population. J Hand Surg Am. 2001 May;26(3):460-6. — View Citation

Shin YH, Yoon JO, Kim YK, Kim JK. Psychological Status Is Associated With Symptom Severity in Patients With Carpal Tunnel Syndrome. J Hand Surg Am. 2018 May;43(5):484.e1-484.e8. doi: 10.1016/j.jhsa.2017.10.031. Epub 2018 Jan 3. — View Citation

Soon B, Vicenzino B, Schmid AB, Coppieters MW. Facilitatory and inhibitory pain mechanisms are altered in patients with carpal tunnel syndrome. PLoS One. 2017 Aug 30;12(8):e0183252. doi: 10.1371/journal.pone.0183252. eCollection 2017. — View Citation

Wolny T, Linek P. Is manual therapy based on neurodynamic techniques effective in the treatment of carpal tunnel syndrome? A randomized controlled trial. Clin Rehabil. 2019 Mar;33(3):408-417. doi: 10.1177/0269215518805213. Epub 2018 Oct 11. — View Citation

Wolny T, Linek P. Neurodynamic Techniques Versus "Sham" Therapy in the Treatment of Carpal Tunnel Syndrome: A Randomized Placebo-Controlled Trial. Arch Phys Med Rehabil. 2018 May;99(5):843-854. doi: 10.1016/j.apmr.2017.12.005. Epub 2018 Jan 4. — View Citation

* Note: There are 24 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Change on Pain Anxiety Symptoms Scale-20 A 20 items scored on a 6-point scale from 0-5. This self-reported scale is used to assess fear of pain and consist of four elements: cognitive anxiety, escape and avoidance, fearful appraisals of pain, and physiological anxiety.
Following scoring indicates severity of symptoms:
mild: 0 to 34 moderate: 35-67 severe 68-100
At baseline and after completion of study at sixth week
Other Change on Center for Epidemiological Studies-Depression scale in scores A 20 items self-report scale that is used to assess depression related symptoms on the basis of frequency over the past week in primary care setting.
Following Scoring indicate severity:
0- 10 or less than 16 : little or no symptoms of depression 16-20 mild symptoms 22 - 25 moderate symptoms 26 -60 severe depression
At baseline and after completion of study at sixth week
Primary Change in pain intensity on Visual Analog Scale in centimeter after sixth week Visual Analog Scale can be defined as a subjective psychometric response scale used to measure distinct behavioral or physiological phenomena based on linear numerical gradient in pain intensity measurement. The patients rate their pain intensity on 0 to 10 cm where 0 cm refers 'no pain' and 10 cm refers 'most excruciating pain'. Increase in number of cm suggests worst pain. At baseline and after completion of study at after sixth week
Primary Change in symptoms severity and functional status on scale of Boston Carpal Tunnel Questionnaire in scores It is a self-administered likert scale, containing two parts, namely the symptom severity scale and the functional status scale. It is used to assess the severity of symptoms and evaluate the difficulty in implementing the designated task. Symptom severity scale contains 11 items and the functional status scale contans 8 items. Higher the score in both scales indicating higher severity and more difficulty in performing the task.
Scoring for Symptoms severity scale:
Less than 11 or 11 = Asymptomatic, 12 to 22 = Mild, 23-33 = Moderate, 24-44 = Severe, 45-55 = Very Severe
Scoring for Functional status scale:
less than 8 or 8 = Asymptomatic, 9-16 = Mild, 17-24 = Moderate, 25-32 = Severe, 33-40 = Very Severe
The total score of both scale is calculated as the mean of the scores for the total items of scale.
At baseline and after completion of study at after sixth week
Primary Change in hand grip strength by using Jamar dynamometer Hand grip strength is quantify in kilogram by using Jamar dynamometer. Measurements was taken three times of each individuals and then calculated mean of these readings. At baseline and after completion of study at sixth week
Primary Change in pinch strength by using Pinch Gauge Pinch grip strength is measured in kilogram by using Pinch Gauge. Measurements was taken three times of each individuals and then calculated mean of these readings. At baseline and after completion of study at sixth week
See also
  Status Clinical Trial Phase
Completed NCT05067205 - Minimal Invasive Carpal Tunnel Release With the Novel Device N/A
Completed NCT03184688 - Platelet Rich Plasma for Carpal Tunnel Syndrome N/A
Completed NCT03582735 - Preoperative Neuromobilization Exercises for Individuals With Carpal Tunnel Syndrome N/A
Completed NCT05490420 - Effects of Upper Extremity Manual Lymphatic Drainage on Symptom Severity, Hand Functions, Electrophysiological and Ultrasonographic Measurements in Carpal Tunnel Syndrome N/A
Recruiting NCT05970692 - Cross-Cultural Adaptation and Psychometric Validation of the Turkish Version of Atroshi-Lyrén 6-item Symptoms Scale
Completed NCT04043780 - Clinical Validation of a Decompression Prototype Splint for Patients With Carpal Tunel Syndrome N/A
Completed NCT03880812 - Cost Information on Carpal Tunnel Syndrome Treatment Decisions N/A
Completed NCT06464809 - Treatment Intervention of Patients With Carpal Tunnel Syndrome (CTS) N/A
Recruiting NCT05372393 - Carpal Tunnel Release Under Local Anaesthesia With or Without Distal Median Nerve Block N/A
Recruiting NCT05328180 - aDjunct bicarbonatE in Local anaesthesIa for CarpAl Tunnel rElease (DELICATE) N/A
Recruiting NCT05503719 - An Absorbable Suture Versus a Non-absorbable Suture in Carpal Tunnel Release, a Randomized Controlled Trial N/A
Completed NCT04060875 - Research Protocol for Karuna Labs Inc.: Safety and Efficacy of Virtual Reality Graded Motor Imagery for Chronic Pain
Not yet recruiting NCT06294821 - 4AP to Delay Carpal Tunnel Release (CTR) Phase 2/Phase 3
Not yet recruiting NCT04328805 - Pain Reduction and Changes in Upper Limb Function Produced by an Ibuprofen Treatment in Carpal Tunnel Syndrome. Phase 4
Terminated NCT02791529 - Scalpel Versus Electrocautery for Surgical Skin Incision in Open Carpal Tunnel Release Phase 1
Completed NCT02141035 - Acetyl-l-carnitine to Enhance Nerve Regeneration in Carpal Tunnel Syndrome Phase 2/Phase 3
Completed NCT01887145 - Comparison of Long-term Outcomes Following Endoscopic or Open Surgery for Carpal Tunnel Syndrome N/A
Recruiting NCT01897272 - Post-Operative Splinting After Short-Incision Carpal Tunnel Release: a Prospective Study N/A
Completed NCT01394822 - Neuromuscular Ultrasound for Focal Neuropathies N/A
Enrolling by invitation NCT01017471 - Carpal Tunnel Syndrome Release Using PSU Retractor Phase 3