NCT06799130

Brief Summary

the aim of this study is to investigate if there is any difference between INSTRUMENT-ASSISTED SOFT TISSUE MOBILIZATION and Muscle Energy Technique over sternocleidomastoid on Neck pain, Range of motion and Functional disability in patients with Chronic Non-specific Neck Pain

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 Jan 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 29, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

January 29, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

January 29, 2025

Status Verified

January 1, 2025

Enrollment Period

2 months

First QC Date

January 23, 2025

Last Update Submit

January 23, 2025

Conditions

Keywords

instrument-assisted soft tissue mobilizationmuscle energy technique

Outcome Measures

Primary Outcomes (1)

  • pain intensity

    the scale that will be used is VAS ; each subject will be instructed to put point on line from no pain to tolerable pain

    up to four weeks

Secondary Outcomes (2)

  • neck range of motion

    up to four weeks

  • neck disability

    up to four weeks

Study Arms (3)

instrument-assisted soft tissue mobilization

EXPERIMENTAL

the patients will receive instrument-assisted soft tissue mobilization twice a week for four weeks over sternocleidomastoid muscle bilaterally utilizing an M2T blade. The subject lay comfortably in supine position on a treatment table. After using alcohol swabs to clean the patient's skin and the blade, a lubricant (Vaseline) will be applied, and a sweeping technique will be utilized to administer a thorough yet comfortable soft tissue mobilization on the sternocleidomastoid from origin to insertion for roughly 3 minutes. conventional therapy the patients will receive hot back for 15 minutes, neck range of motion (ROM), chin tuck, stretches and strengthen exercise.

Other: instrument-assisted soft tissue mobilizationOther: Muscle energy technique

Muscle energy technique

EXPERIMENTAL

the patients will receive post-isometric muscle relaxation(PIR) treatment for the sternocleidomastoid muscle, it will be applied from supine lying position with the head free from the plinth and held by the therapist's hand, the therapist placed one hand opposite the side of involvement muscle , The other hand is placed on the involved side of muscle . The patient pushed upward against the therapist's thumb on the forehead and looked up, then the patient will be asked to stop pushing and look down. After relaxation therapist will stretch the muscle for 30 seconds. This will be repeated 3 times bilaterally for 3 sessions per week for four weeks. conventional therapy the patients will receive hot back for 15 minutes, neck range of motion, chin tuck, stretches and strengthen exercise.

Other: instrument-assisted soft tissue mobilizationOther: Muscle energy technique

conventional therapy

ACTIVE COMPARATOR

the patients will receive conventional therapy three times a week for four weeks conventional therapy the patients will receive hot back for 15 minutes, neck range of motion (ROM), chin tuck, stretches and strengthen exercise.

Other: instrument-assisted soft tissue mobilizationOther: Muscle energy technique

Interventions

instrument-assisted soft tissue mobilization

Also known as: IASTM
Muscle energy techniqueconventional therapyinstrument-assisted soft tissue mobilization

Muscle energy technique

Muscle energy techniqueconventional therapyinstrument-assisted soft tissue mobilization

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The subjects are of both genders, aged between 18-35 years old .
  • Subjects with Neck pain continued for at least the last 12 weeks .
  • body mass index (18.5-24.9).

You may not qualify if:

  • Any specific neck pathology as radiculopathy, rheumatoid arthritis, and systemic diseases
  • Sensory problems at the mid or upper back .
  • A tendency to hemorrhage or anticoagulation treatment. And nonsteroidal pain medication .
  • Signs of severe pathology such as malignancy, fractures of the cervical spine, cervical radiculopathy or myelopathy, or vascular syndromes such as vertebrobasilar insufficiency .
  • surgery of the cervical spine, whiplash trauma (in the past or recent, as cause of the complaint).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alaa Mohamed Hassan Saleh

Cairo, 00, Egypt

Location

Study Officials

  • alaa saleh

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: instrument assisted soft tissue mobilization and muscle energy technique
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 23, 2025

First Posted

January 29, 2025

Study Start

January 29, 2025

Primary Completion

March 15, 2025

Study Completion

March 30, 2025

Last Updated

January 29, 2025

Record last verified: 2025-01

Locations