Effects of Kaltenborn and Mulligan Mobilisation in Patients With Carpal Tunnel Syndrome.

NCT ID: NCT06687018

Last Updated: 2024-11-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-04
• Study Completion Date: 2025-01-07

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.

Conditions

Carpal Tunnel Syndrome (CTS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Kaltenborn mobilisation

Kaltenborn mobilisation along with conventional treatment.

Group Type: EXPERIMENTAL

Kaltenborn mobilisation

Intervention Type: OTHER

Kaltenborn mobilisation Grade 3 along with common treatment for 3 minutes, repeated 3 sets with rest of 1 minutes, three sessions per week for four weeks. Conventional treatment comprises a hot pack for 10 minutes, SWD for 5 minutes, and nerve and tendon gliding exercises.

Mulligan mobilisation

Mulligan mobilisation along with conventional treatment.

Group Type: ACTIVE_COMPARATOR

Mulligan mobilisation

Intervention Type: OTHER

Mulligan mobilisation with 10 repetitions with 3 sets and three sessions per week for four weeks. Conventional treatment comprises a hot pack for 10 minutes, SWD for 5 minutes, and nerve and tendon gliding exercises

Interventions

Kaltenborn mobilisation

Kaltenborn mobilisation Grade 3 along with common treatment for 3 minutes, repeated 3 sets with rest of 1 minutes, three sessions per week for four weeks. Conventional treatment comprises a hot pack for 10 minutes, SWD for 5 minutes, and nerve and tendon gliding exercises.

Intervention Type: OTHER

Mulligan mobilisation

Mulligan mobilisation with 10 repetitions with 3 sets and three sessions per week for four weeks. Conventional treatment comprises a hot pack for 10 minutes, SWD for 5 minutes, and nerve and tendon gliding exercises

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ali Raza, MS-OMPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Ejaz Hospital

Lahore, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Imran Amjad, Phd

Role: CONTACT

Imran.amjad@riphah.edu.pk

03324390125

Imran Amjad, Phd

Role: CONTACT

Imran.amjad@riphah.edu.pk

051-5481826

Facility Contacts

Aqeel Ilyas, MS-NMPT

Role: primary

ilyassaqeel@gmail.com

+923037862835

References

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.

Reference Type: BACKGROUND

PMID: 28825339 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33855879 (View on PubMed)

Exelby L. Peripheral mobilisations with movement. Man Ther. 1996 Jun;1(3):118-126. doi: 10.1054/math.1996.0259.

Reference Type: BACKGROUND

PMID: 11440498 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28447963 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36442295 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32509244 (View on PubMed)

Other Identifiers

REC/RCR & AHS/24/0129

Identifier Type: -

Identifier Source: org_study_id