NCT06720116

Brief Summary

this study will be conducted to investigate the effect of sustained natural apophysial glide and Instrument assisted soft tissue mobilization on pain intensity, cervical range of motion and neck functional disability level in patients with chronic mechanical neck pain

Trial Health

35
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 Dec 2024

Shorter than P25 for not_applicable

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

December 3, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

December 10, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

December 6, 2024

Status Verified

November 1, 2024

Enrollment Period

4 months

First QC Date

December 3, 2024

Last Update Submit

December 3, 2024

Conditions

Keywords

Sustained Natural Apophysial Glideinstrument Assisted Soft Tissue MobilizationChronic Mechanical Neck Pain

Outcome Measures

Primary Outcomes (1)

  • neck disability

    Assessment of neck disability will be performed by Arabic version of neck disability index .It is valid and reliable tool in the assessment of neck function. The NDI can be calculated as a raw score or as a percentage Each segment is graded on a scale of 0 to 5, with 0 representing "no discomfort" and 5 suggesting "the most excruciating pain imaginable." With a maximum score of 50 as following

    up to four weeks

Secondary Outcomes (2)

  • pain intensity

    up to four weeks

  • cervical range of motion

    up to four weeks

Study Arms (3)

sustained natural apophysial glide

EXPERIMENTAL

patients will receive sustained natural apophysial glide( SNAGS ) in addition to conventional therapy in the form of ( Infrared, TENS , stretching exercices, isometric exercises) for chronic mechanical neck pain ,3 sessions per week for one month

Other: sustained natural apophysial glideOther: conventional physical therapy

instrument assisted soft tissue mobilization

EXPERIMENTAL

patients will receive instrument assisted soft tissue mobilization ( IASTM) technique in addition to conventional therapy in the form of ( Infrared, TENS , stretching exercices, isometric exercises) for chronic mechanical neck pain ,3 sessions per week for one month.

Other: instrument assisted soft tissue mobilizationOther: conventional physical therapy

conventional therapy

ACTIVE COMPARATOR

patients will receive conventional therapy in the form of ( Infrared, TENS , stretching exercices, isometric exercises) for chronic mechanical neck pain ,3 sessions per week for one month.

Other: conventional physical therapy

Interventions

The patients will be in the sitting position and asked to move their head in the direction that particularly produces their symptoms. As the participant moves their head, the physiotherapist gently glides the painful vertebra anteriorly and sustains the glide through the movement. During the application of the glide, the participant should stay symptom free and is instructed to stop moving if any PAIN is produced. This movement was repeated for 10 times for 3 sets, The interval between the sets was 15 to 20 seconds.After mobilization subject had to perform same exercises as conventional group plus conventional physical therapy

sustained natural apophysial glide

The subject will be in comfortable sitting position leaning on a treatment table with the arm crossed to rest the head. After cleaning the skin of the subject and the blade with alcohol swabs, a lubricant (Vaseline) was applied, and a sweeping technique was used to apply a deep yet comfortable soft tissue mobilization on the upper trapezius from origin to insertion for approximately 3 min. First, M2T blade will be utilized to locate the precise locations of limitation in the affected muscles. Second, the M2T blade was put at 45 degree angle by using convex surface to apply gentle strokes along the muscle. Subjects were instructed that slight hyperemia on the skin is a normal feeling and should subside before the next session.

instrument assisted soft tissue mobilization

the patients will receive conventional physical therapy in the form of Infrared, TENS , stretching exercices, isometric exercises

conventional therapyinstrument assisted soft tissue mobilizationsustained natural apophysial glide

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Sixety patients of chronic mechanical neck pain diagnosed and reffered from physicians will be participants in the study .
  • Patients of both genders will be included.
  • The age of the participants will beranged from 20 and 55 years
  • The BMI ranged between 18.9 and 25 kg/m2
  • All patients who suffered from neck pain more than 3 months.

You may not qualify if:

  • Malignancy
  • cervical and cranial surgery
  • Recent fractures
  • spinal tumors
  • severe disc herniation
  • uncontrolled hypertension
  • Heart Disease ( arrhythmia, pacemaker).
  • Pregnant and breast feeding women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

menna allah abd elfatah, master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
opaque sealed envelope
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: mulligan and iASTM groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator : menna allah hesham abd elfatah

Study Record Dates

First Submitted

December 3, 2024

First Posted

December 6, 2024

Study Start

December 10, 2024

Primary Completion

March 30, 2025

Study Completion

March 30, 2025

Last Updated

December 6, 2024

Record last verified: 2024-11