NCT06468904

Brief Summary

The purpose of this study is to examine effect of cervical stabilization exercises on hand grip strength, key pinch strength, pain intensity, pain pressure threshold and hand function in chronic myofascial neck pain patients.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
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 Start

First participant enrolled

October 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 21, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

10 months

First QC Date

June 5, 2024

Last Update Submit

June 24, 2024

Conditions

Keywords

cervical stabilizationhand gripmyofascial neck pain

Outcome Measures

Primary Outcomes (1)

  • primary outcome measure

    hand grip strength was measured by hand held dynamometer.

    up to four weeks

Secondary Outcomes (4)

  • secondary outcome measures

    up to four weeks

  • secondary outcome measure

    up to four weeks

  • secondary outcome measure

    up to 4 weeks

  • secondary outcome measure

    up to four weeks

Study Arms (2)

cervical stabilization exercises and integrated neuromuscular inhibition technique

EXPERIMENTAL

patients received cervical stabilization exercises and integrated neuromuscular inhibition technique for 3 sessions / week for 4 weeks. Cervical stabilization included chin tucks, isometric holds, ball squeeze. Integrated neuromuscular inhibition technique included: 1. ischemic compression: therapist applied an intermittent ischemic compression on upper trapezius trigger point by thumb for 90sec. 2. Strain counter-strain: therapist applied pressure at trigger point. patient's head was laterally flexed towards the affected side passively by one hand of the therapist. The other hand held the subject's forearm and moved the affected shoulder to 90degree of abduction and external rotation for 90 secs. 3. Muscle energy technique: patient laterally flexed the neck to opposite side patient was moved the stabilized shoulder and ear towards each other. The contraction was maintained for 10 sec followed by 5 seconds of relaxation. The muscle was stretched for 30 secs.

Procedure: cervical stabilization exercises and integrated neuromuscular technique.

Integrated neuromuscular inhibition technique

ACTIVE COMPARATOR

patients received integrated neuromuscular inhibition technique for 3 sessions / week for 4 weeks.it included Ischemic compression, Strain counter-strain and muscle energy technique. 1. ischemic compression. therapist applied an intermittent ischemic compression on upper trapezius trigger point by thumb for 90 sec. 2. Strain counter-strain: therapist applied pressure at trigger point. patient laterally flexed towards the affected side passively by one hand of the therapist. The other hand held the subject's forearm and moved the affected side shoulder passively to 90degree of abduction and external rotation for 90 secs. 3. Muscle energy technique: patient was asked to laterally flex the neck to opposite side. patient was requested to move the stabilized shoulder and ear towards each other. The contraction was maintained for 10 sec followed by 5 seconds of relaxation. The muscle was stretched for 30 secs.

Procedure: cervical stabilization exercises and integrated neuromuscular technique.

Interventions

Patients received cervical stabilization exercises and integrated neuromuscular inhibition technique. Cervical stabilization protocol included strengthening exercises of deep cervical flexors muscles which included chin tucks, isometric holds, ball squeeze, as well as deep cervical extensors muscles which included cranio-cervical flexion from neutral, upper cervical rotation and extension of cervical spine. integrated technique includes ischemic compression, muscle energy technique and strain counter strain.

Integrated neuromuscular inhibition techniquecervical stabilization exercises and integrated neuromuscular inhibition technique

Eligibility Criteria

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

You may qualify if:

  • Chronic neck pain for more than 3 months.
  • Active MTrPs in the UT muscle with a tender nodule.
  • Constant neck pain, a jump sign during palpation of UT muscle.
  • Referred pain.
  • Symptoms of ipsilateral hand muscles weakness.

You may not qualify if:

  • Signs of severe pathology such as malignancy of the cervical area.
  • Fractures of the cervical spine.
  • Cervical radiculopathy or myelopathy.
  • Diabetes.
  • Trauma, congenital anomalies and surgery around neck, shoulder and hand.
  • Fibromyalgia or vascular syndromes such as vertebra-basilar insufficiency.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cairo University

Giza, 11251, Egypt

COMPLETED

Faculty of physical therapy

Giza, 11251, Egypt

RECRUITING

Study Officials

  • soheir sh Rezkallah, PHD

    professor of physaical therapy

    STUDY DIRECTOR
  • Ghada Abd Elmoneim, PHD

    assistant professor of physical therapy

    STUDY DIRECTOR
  • Haidy S Roshdy, PHD

    lecturer of physical therapy

    STUDY DIRECTOR

Central Study Contacts

Fatma Alzahraa M Ali, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double (investigator, outcome assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: cervical stabilization exercises
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle invesyigator

Study Record Dates

First Submitted

June 5, 2024

First Posted

June 21, 2024

Study Start

October 1, 2023

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

June 26, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations