Clinical trial NCT06687018: Effects of Kaltenborn and Mulligan Mobilisation in Patients With Carpal Tunnel Syndrome.
Official title: Comparative Effects of Kaltenborn Versus Mulligan Mobilisation on Pain, Disability and Hand Function in Patients With Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carpal Tunnel Syndrome (CTS)
Keywords: Kaltenborn, Mulligan, Pain, Disability, Hand Function, CTS
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Carpal Tunnel Syndrome is the most common mononeuropathy that results from the compression of median nerve in carpal tunnel, leading to entrapment neuropathy. The symptoms become aggravated during drawing, typing or playing video games. The aim of study will be to compare the effects of Kaltenborn and Mulligan mobilisation on pain, disability and hand function in patients with carpal tunnel syndrome.

Detailed description: This research will adopt a Randomized Clinical Trial design. Upon approval of the synopsis, ethical clearance would be taken and necessary permissions from Ejaz Hospital Lahore. Through convenience sampling technique, 48 patients will be included which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Mobilisation technique includes moving the proximal row of carpal bones either dorsally to promote wrist extension or to the palmar side to promote wrist flexion. Group A will be treated with Grade 3 Kaltenborn mobilisation. Grade 3 distraction was chosen to avoid contact between the articular surfaces and to stimulate hypoalgesic factors and Group B will be treated with Mulligan mobilisation. Outcome measures will be conducted through pain, disability and hand function questionnaire after 6 weeks. Data will be analyzed during SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Eligibility criteria: Inclusion Criteria:

* Both genders between 20 and 45 years of age
* Individuals having localized pain, tingling and numbness in the median nerve distribution
* Positive Tinel sign and positive Phalen's test

Exclusion Criteria:

* Any sensory and/or motor deficit in either the ulnar or radial nerve traumatic neck injury
* Previous hand surgery or trauma or cervical radiculopathy
* Systemic disease e.g. diabetes mellitus or thyroid disease or rheumatoid arthritis

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 4 weeks
measure: Boston Carpal Tunnel Questionnaire
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Ejaz Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Ali Raza, MS-OMPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bougea A, Zambelis T, Voskou P, Katsika PZ, Tzavara C, Kokotis P, Karandreas N. Reliability and Validation of the Greek Version of the Boston Carpal Tunnel Questionnaire. Hand (N Y). 2018 Sep;13(5):593-599. doi: 10.1177/1558944717725379. Epub 2017 Aug 20.
citation: Abdolrazaghi HA, Khansari M, Mirshahi M, Ahmadi Pishkuhi M. Effectiveness of Tendon and Nerve Gliding Exercises in the Treatment of Patients With Mild Idiopathic Carpal Tunnel Syndrome: A Randomized Controlled Trial. Hand (N Y). 2023 Mar;18(2):222-229. doi: 10.1177/15589447211006857. Epub 2021 Apr 15.
citation: Exelby L. Peripheral mobilisations with movement. Man Ther. 1996 Jun;1(3):118-126. doi: 10.1054/math.1996.0259.
citation: Spagnoli AM, Fino P, Fioramonti P, Sanese G, Scuderi N. Bifid median nerve and carpal tunnel syndrome: an uncommon anatomical variation. Ann Ital Chir. 2017;88:95-96.
citation: Li ZM, Jordan DB. Carpal tunnel mechanics and its relevance to carpal tunnel syndrome. Hum Mov Sci. 2023 Feb;87:103044. doi: 10.1016/j.humov.2022.103044. Epub 2022 Nov 25.
citation: Talebi GA, Saadat P, Javadian Y, Taghipour M. Comparison of two manual therapy techniques in patients with carpal tunnel syndrome: A randomized clinical trial. Caspian J Intern Med. 2020;11(2):163-170. doi: 10.22088/cjim.11.2.163.