NCT07068698

Brief Summary

This randomized controlled study will aim to investigate the effects of thumb manipulation on hand grip strength, function, and sensation in healthy individuals. A total of 60 volunteers aged between 18 and 50 years will be recruited from Ortadağ Special Education and Rehabilitation Center. Participants will be randomly assigned to either a chiropractic manipulation group (n=30) or a control group (n=30), with an equal distribution of males and females in each group. The intervention group will receive thumb manipulation twice weekly for 4 weeks, while the control group will not receive any intervention. Outcome measures will include two-point discrimination (assessed with a discriminator), hand grip strength (measured using a dynamometer), pinch strength (evaluated with a pinch meter), and hand function (measured by the Duruöz Hand Index). Statistical analyses will be performed with a significance level set at p\<0.05. It is expected that participants in the manipulation group will show greater improvements in all measured parameters compared to the control group, suggesting a positive effect of thumb manipulation on hand-related sensorimotor functions in healthy individuals.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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

July 6, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 7, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2025

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

1 month

First QC Date

July 7, 2025

Last Update Submit

July 7, 2025

Conditions

Keywords

Thumb manipulationChiropracticHand grip strengthHand functionHealthy individuals

Outcome Measures

Primary Outcomes (3)

  • Duruoz Hand Index

    The Duruöz Hand Index is a validated self-reported questionnaire used to assess hand function and disability in daily activities. It includes 18 items covering various tasks such as dressing, hygiene, kitchen activities, and carrying objects. Each item is scored on a scale from 0 (no difficulty) to 5 (unable to perform), with higher scores indicating greater hand disability.

    T0 (Baseline, before intervention), T1 (Week 2 of intervention), and T2 (Week 4, end of intervention

  • Two-Point Discrimination Test

    The Two-Point Discrimination Test is used to evaluate sensory perception and tactile acuity. It measures the smallest distance at which two points of contact can be perceived as separate. In this study, the test will be applied to the thumb (right and left) using a standardized discriminator tool. Lower discrimination distances indicate better sensory perception. The test provides objective data on changes in cutaneous sensory function.

    T0 (Baseline, before intervention), T1 (Week 2 of intervention), and T2 (Week 4, end of intervention)

  • Pinchmeter

    Pinch strength will be measured using a standardized pinchmeter to assess lateral, palmar, and tip-to-tip pinch strength in the thumb, index, and middle fingers of both hands. The test will provide quantitative data on fine motor strength and thumb function. Higher values indicate increased pinch strength. The measurement will be used to evaluate the effect of thumb manipulation on hand function.

    T0 (Baseline, before intervention), T1 (Week 2 of intervention), and T2 (Week 4, end of intervention)

Study Arms (2)

Chiropractic Manipulation Group (CMG)

EXPERIMENTAL

Participants in this group will receive chiropractic manipulation specifically applied to the thumb. The intervention will be administered twice a week for 4 weeks by a trained physiotherapist experienced in manual therapy techniques. Each session will involve standardized manipulation techniques aimed at improving thumb mobility, hand grip strength, sensory function, and overall hand function. No additional interventions or therapies will be provided during the study period.

Other: Thumb Manipulation

Control Group (CG)

NO INTERVENTION

Participants in the control group will not receive any intervention or treatment during the 4-week study period. They will continue their usual daily activities without any specific therapy applied. Outcome measurements will be conducted at the same time points as the intervention group to allow for comparison.

Interventions

This intervention consists of chiropractic manipulation techniques applied specifically to the thumb joint. The manipulation will be performed by a trained physiotherapist twice weekly for 4 weeks. The procedure aims to improve thumb joint mobility, hand grip strength, sensory function, and overall hand function. Each session includes standardized manual therapy maneuvers targeting the thumb's range of motion and soft tissue mobility without the use of any devices or medications. The intervention differs from other manual therapies by focusing solely on the thumb region.

Also known as: Chiropractic Thumb Manipulation, Manual Thumb Mobilization
Chiropractic Manipulation Group (CMG)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 18 and 50
  • Willing to participate in the study
  • Have signed the informed consent form
  • Able to use verbal and written communication skills

You may not qualify if:

  • Having contraindications that may prevent manipulation
  • Having a history of congenital or acquired orthopedic or neurological conditions affecting the upper extremity
  • Having a history of rheumatological diseases
  • Having a history of trauma or surgery affecting the upper extremity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sinop University

Sinop, Turkey (Türkiye)

Location

Study Officials

  • SEFA H HATIK

    Sinop University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

SEFA H HATIK, Asst. Prof.

CONTACT

OMER D KIZIL, PhD.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessors will be blinded to the group assignments to reduce measurement bias. Participants will be aware of their group allocation due to the nature of the intervention (the control group does not receive any treatment). The care providers performing the manipulation will not be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Asst. Professor

Study Record Dates

First Submitted

July 7, 2025

First Posted

July 16, 2025

Study Start

July 6, 2025

Primary Completion

August 6, 2025

Study Completion

September 6, 2025

Last Updated

July 16, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations