NCT07624188

Brief Summary

This study will be conducted to investigate the effect of sensory motor training for neck muscles on hand grip strength in post-menopausal fibromyalgia neck pain.

Trial Health

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Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Jun 2026

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

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Study Timeline

Key milestones and dates

Study Progress9%
Jun 2026Oct 2026

First Submitted

Initial submission to the registry

May 28, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2026

Expected
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

June 3, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

May 28, 2026

Last Update Submit

May 28, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Assessment of hand grip strength

    The hand-held dynamometer (Hoggan Health Industries, Salt Lake City, USA) is an enclosed hydraulic system recording the applied strength in kilograms. Hand grip strength will be measured for all participants in both groups before and after the end of the study. Each participant in both groups will be asked to place hand-held dynamometer in her hand, with her arm beside the trunk, the shoulder in a neutral position, the elbow flexed at 90° and to pull the metal bar with her fingers. This procedure will be conducted bilaterally. The mean of three trials for each side (with 3 min resting periods between repetitions to avoid fatigue) will be calculated

    4 weeks

  • Assessment of Disability of the Arm, Shoulder and Hand (DASH)

    This 30-item tool evaluates symptoms along with physical function, specifically focusing on the level of disability, and offers five response options for each item. Each item offers five response options, spanning from 1, indicating "no difficulty or symptoms present," to 5, indicating "incapable of participating in an activity or experiencing very severe symptoms." Greater score on the DASH indicates increased levels of disability. The DASH score is used to assess upper limb disability, with higher scores indicating greater impairment. A score of 0 reflects no disability, 1-20 indicates mild disability, 21-40 is moderate, 41-60 is severe, and 61-100 represents very severe disability.

    4 weeks

  • Assessment of neck pressure pain threshold

    The force dial FDK 20 algometer is a handheld device used to assess the pressure pain threshold (PPT), which is the minimum amount of pressure that induces a sensation of pain. It provides an objective measure of mechanical pain sensitivity in neck. Each participant will be asked to assume upright position with feet flat, arms relaxed, and neck in a neutral position. Pressure will be applied perpendicularly to the site of pain at a constant rate of 1 kg/cm² per second. Each participant will be instructed to indicate when the sensation changed from pressure to the first feeling of pain. Three readings will be taken at each site with 30-60 seconds rest between trials, and the average will be recorded as the final PPT value

    4 weeks

  • Assessment of pain intensity

    The visual analogue scale will be used to assess pain intensity. It is a subjective method to determine pain intensity. The scale consists of a 10-centimeter horizontal line, with the left end marked as "no pain" (0) and the right end marked as "worst possible pain" (10).

    4 weeks

Study Arms (2)

Neuro dynamic nerve gliding exercises

ACTIVE COMPARATOR

The participants will receive neuro dynamic nerve gliding exercises in the form of median, radial and ulnar nerve gliding exercises for 50 minutes/session.

Other: Neuro dynamic nerve gliding exercises

Sensory motor neck training and neuro dynamic nerve gliding exercises

EXPERIMENTAL

The participants will receive sensory motor neck training using laser pointer technique for 15 minutes/session, 3 times/week for four weeks in addition to neuro dynamic nerve gliding exercises in the form of median, radial and ulnar nerve gliding exercises for 50 minutes/session.

Other: Neuro dynamic nerve gliding exercisesOther: Sensory motor neck training

Interventions

The participants will receive neuro dynamic nerve gliding exercises in the form of median, radial and ulnar nerve gliding exercises for 50 minutes/session (for 15 repetitions, each repetition held for 1-2 minutes with 30 seconds rest intervals between each repetition)

Neuro dynamic nerve gliding exercisesSensory motor neck training and neuro dynamic nerve gliding exercises

The participants will perform sensory motor neck training by using laser pointer exercise for 15 minutes/session, 3times/ week for four weeks. * The laser pointer exercise will be positioned exactly in the center of the participants' forehead and parallel to the ground. * Each participant will assume sitting position on comfortable chair at 90cm (about 3 feet) away from the target board (circles shapes), their knees and hips at 90°, their pelvis and low back resting firmly against the back of a chair and their hands resting on their knees. * Therapist will be behind the patient and will give her instructions. * Align the laser so that it will point straight at the center of the target when the head is in a neutral position * at 90 cm away from the target board. * The patient will move the head (flexion/extension/rotation), then attempts to return to the starting position * Five repetitions will be performed for each movement direction

Sensory motor neck training and neuro dynamic nerve gliding exercises

Eligibility Criteria

Age50 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Fifty post-menopausal women clinically diagnosed with fibromyalgia neck pain for more than 3 months.
  • Their age will be ranged from 50-60 years old.
  • Their body mass index (BMI) will be less than 30 kg/m².
  • Their hand grip strength is less than 20 kg for dominant hand as measured by hand-held dynamometer.
  • Their neck pain score is ≥ 4 as measured by the visual analogue scale (VAS).
  • The right hand is the dominant for all of them.

You may not qualify if:

  • Participants will be excluded from the study if they have:
  • Recent cervical trauma or surgery.
  • Neurological disorders.
  • Diabetes mellitus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Esraa Fikry Massoud

Cairo, Egypt

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mohamed Kaddah, Professor

    Cairo University

    STUDY DIRECTOR
  • Azza Nashed, Professor

    Cairo University

    STUDY CHAIR

Central Study Contacts

Esraa Massoud, Master

CONTACT

Afaf Botla, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 28, 2026

First Posted

June 3, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

June 3, 2026

Record last verified: 2026-05

Locations