NCT06687018

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2025

Completed
Last Updated

November 13, 2024

Status Verified

November 1, 2024

Enrollment Period

1 year

First QC Date

November 12, 2024

Last Update Submit

November 12, 2024

Conditions

Keywords

Kaltenborn, Mulligan, Pain, Disability, Hand Function, CTS

Outcome Measures

Primary Outcomes (2)

  • Numeric Pain Rating Scale

    Changes from baseline, Numeric Rating Scale (NRS) is the most commonly used scale in which the pain rate ranges from 0 (no pain) to 10 (worst pain). The NPRS has validity of 0.86 to 0.95 and reliability of 0.96.

    4 weeks

  • Boston Carpal Tunnel Questionnaire

    Questionnaire used to assess functional status and symptom severity. There are two subscales in BCTQ. The Functional Status Scale evaluates hand function, whereas the Symptom Severity Scale (SSS) provides PRO data on the degree of symptoms. Eleven items make up the Symptom Severity scale, which rates symptoms related to pain, paresthesia, numbness, weakness, and grasping trouble. Eight items make up the Functional Status Scale (FSS), which evaluates functional deficiencies. Form 1 (no symptoms/difficulties) to 5 (worst symptoms/cannot do the task at all) each item is graded.(20). In BCQT, SSS has reliability 0.89 and FSS has 0.93.

    4 weeks

Study Arms (2)

Kaltenborn mobilisation

EXPERIMENTAL

Kaltenborn mobilisation along with conventional treatment.

Other: Kaltenborn mobilisation

Mulligan mobilisation

ACTIVE COMPARATOR

Mulligan mobilisation along with conventional treatment.

Other: Mulligan mobilisation

Interventions

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.

Kaltenborn 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

Mulligan mobilisation

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ejaz Hospital

Lahore, Punjab Province, Pakistan

RECRUITING

Related Publications (6)

  • 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.

    PMID: 28825339BACKGROUND
  • 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.

    PMID: 33855879BACKGROUND
  • Exelby L. Peripheral mobilisations with movement. Man Ther. 1996 Jun;1(3):118-126. doi: 10.1054/math.1996.0259.

    PMID: 11440498BACKGROUND
  • 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.

    PMID: 28447963BACKGROUND
  • 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.

    PMID: 36442295BACKGROUND
  • 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.

    PMID: 32509244BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel SyndromePain

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ali Raza, MS-OMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2024

First Posted

November 13, 2024

Study Start

January 4, 2024

Primary Completion

January 7, 2025

Study Completion

January 7, 2025

Last Updated

November 13, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations