NCT05650970

Brief Summary

Hand-thumb carpometacarpal (1st CMC) joint osteoarthritis is defined as the degeneration occurring between the articular surfaces of the 1st metacarpal bone and the trapezium bone. This degeneration causes deterioration in the cartilage tissue that forms the joint structure, and as a result, patients primarily complain of pain and related loss of function. Clinical observations and studies have shown that the level of pain expressed by patients is not always compatible with the amount of degeneration in the joint. In addition, it has been clearly stated in the studies that the pain complaints of the patients are not only due to the changes in the joint, but the irritation of the nerves that receive the sensation of this joint is also effective in the level of pain. In line with the findings of the studies on this subject, mobilization exercise for the relevant nerve is included in the treatment programs of patients diagnosed with 1st CMC joint osteoarthritis in the clinic for a while. The investigators observed that the radial nerve mobilization exercise given during the process contributed to the improvement in the pain level of the patients. The investigators planned our study because there was no publication in the literature examining this effect. This study aims to investigate the effect of radial nerve mobilization exercise on pain level, functional status, and grip strength of patients diagnosed with 1st CMC joint osteoarthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 28, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 14, 2022

Completed
22 days until next milestone

Study Start

First participant enrolled

January 5, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2023

Completed
Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

11 months

First QC Date

November 28, 2022

Last Update Submit

February 16, 2025

Conditions

Keywords

osteoarthritismobilizationradial nervecarpometacarpal jointthumb

Outcome Measures

Primary Outcomes (1)

  • Pain level assessment at rest, activity and at night with a visual analog scale (VAS)

    Patients will be asked to mark the value corresponding to the pain levels they feel in three different situations, resting, activity and night, on a line drawn with a length of 10 cm. The level of the marked point will be recorded in cm. 0 point corresponding to the lowest value will be described as I have no pain, 10 points corresponding to the highest value will be described as I have extreme unbearable pain.

    4 week

Secondary Outcomes (2)

  • gross and fine grip strength assessment

    4 week

  • Functional status assessment with FIHOA (Functional Index of Hand Osteoarthritis) and (Michigan Hand Outcomes Questionnaires-MHOQ)

    4 week

Study Arms (2)

routinely treated control group

ACTIVE COMPARATOR

Unlike the study group, radial nerve mobilization will not be included in the treatment program of this group. only massage, ice and activity modification training will be included.

Other: routine therapy

radial nerve mobilization study group

EXPERIMENTAL

The treatment program of this group will include massage, radial nerve mobilization, ice and activity modification training.

Other: radial nerve mobilization exercise

Interventions

Routine treatment program including massage, ice and activity training applied to hand thumb osteoarthritis patients

routinely treated control group

Radial nerve mobilization exercise in addition to the routine treatment program applied to patients with hand thumb osteoarthritis

radial nerve mobilization study group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Hand-thumb Osteoarthritis Disease Must have pain

You may not qualify if:

  • Wrist surgery history Poor communication Poor mental state

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Health Science Faculty Physiotherapy and Rehabilitation Department

Yenimahalle, Ankara, Turkey (Türkiye)

Location

Related Publications (5)

  • Sousa-Santos AR, Amaral TF. Differences in handgrip strength protocols to identify sarcopenia and frailty - a systematic review. BMC Geriatr. 2017 Oct 16;17(1):238. doi: 10.1186/s12877-017-0625-y.

    PMID: 29037155BACKGROUND
  • Bohannon RW, Bubela DJ, Magasi SR, Gershon RC. Relative reliability of three objective tests of limb muscle strength. Isokinet Exerc Sci. 2011;19(2):10.3233/IES-2011-0400. doi: 10.3233/IES-2011-0400.

    PMID: 24339479BACKGROUND
  • Poole JL. Measures of hand function: Arthritis Hand Function Test (AHFT), Australian Canadian Osteoarthritis Hand Index (AUSCAN), Cochin Hand Function Scale, Functional Index for Hand Osteoarthritis (FIHOA), Grip Ability Test (GAT), Jebsen Hand Function Test (JHFT), and Michigan Hand Outcomes Questionnaire (MHQ). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S189-99. doi: 10.1002/acr.20631. No abstract available.

    PMID: 22588744BACKGROUND
  • Dreiser RL, Maheu E, Guillou GB, Caspard H, Grouin JM. Validation of an algofunctional index for osteoarthritis of the hand. Rev Rhum Engl Ed. 1995 Jun;62(6 Suppl 1):43S-53S.

    PMID: 7583182BACKGROUND
  • Moe RH, Garratt A, Slatkowsky-Christensen B, Maheu E, Mowinckel P, Kvien TK, Kjeken I, Hagen KB, Uhlig T. Concurrent evaluation of data quality, reliability and validity of the Australian/Canadian Osteoarthritis Hand Index and the Functional Index for Hand Osteoarthritis. Rheumatology (Oxford). 2010 Dec;49(12):2327-36. doi: 10.1093/rheumatology/keq219. Epub 2010 Aug 11.

    PMID: 20702486BACKGROUND

MeSH Terms

Conditions

Joint DiseasesRadial NeuropathyOsteoarthritis

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesArthritisRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The 40 people included in the study will be equally placed in the control and study groups in the order they applied to the clinic. Individuals in the two study groups will be included in an exercise program two days a week, accompanied by a physiotherapist for 4 weeks. The only difference between the groups is the content of the treatment programs.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 28, 2022

First Posted

December 14, 2022

Study Start

January 5, 2023

Primary Completion

November 23, 2023

Study Completion

December 23, 2023

Last Updated

February 18, 2025

Record last verified: 2025-02

Locations