Carpal Tunnel Syndrome Clinical Trial
Official title:
Effects of Soft Tissue Massage Along With Mobilization Technique on Intensity of Symptoms and Functional Status of Carpal Tunnel Syndrome - A Randomized Controlled Trial
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Pakistan | Sindh Institute of Physical Medicine and Rehabilitation | Karachi | Sindh |
Lead Sponsor | Collaborator |
---|---|
Dow University of Health Sciences |
Pakistan,
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 all — Click here to view all references
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 |
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 |