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NCT Number: NCT06687018

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

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.

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Key information

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ejaz Hospital

Lahore, Punjab Province, Pakistan

Location status: Recruiting

Location contact

Aqeel Ilyas, MS-NMPT

CONTACT

[email protected]

+923037862835

Muhammad Nauman, MS-OMPT

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kaltenborn mobilisation

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

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

Primary outcomes

  1. Numeric Pain Rating Scale

    Time frame: 4 weeks

    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.

  2. Boston Carpal Tunnel Questionnaire

    Time frame: 4 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Imran Amjad, Phd

CONTACT

[email protected]

03324390125

Imran Amjad, Phd

CONTACT

[email protected]

051-5481826

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Comparative Effects of Kaltenborn Versus Mulligan Mobilisation on Pain, Disability and Hand Function in Patients With Carpal Tunnel Syndrome

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 13, 2024
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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