NCT05557747

Brief Summary

This study will be conducted to identify the difference between the effect of of cervicothoracic junction mobilization and autogenic Muscle Energy Technique. on neck pain, cervical range of motion, cervical proprioception and neck disability in mechanical neck pain patients with cervicothoracic junction hypomobility.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 24, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 28, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

August 28, 2023

Status Verified

August 1, 2023

Enrollment Period

9 months

First QC Date

September 24, 2022

Last Update Submit

August 25, 2023

Conditions

Keywords

chronic mechanical neck paincervicothoracic junction mobilizationautogenic muscle energy techniquecervicothoracic junction hypomobility

Outcome Measures

Primary Outcomes (1)

  • change in neck pain

    change in neck pain will be measured by Visual analog scale for the 3 groups pre- and post treatment

    Evaluation Will be performed prior to the first treatment session; as a baseline measure, and at last treatment session(after 4 weeks) as a post-treatment measure

Secondary Outcomes (1)

  • cervical ROM and cervical prorprioception

    Evaluation Will be performed prior to the first treatment session; as a baseline measure, and at last treatment session(after 4 weeks) as a post-treatment measure

Study Arms (3)

Group A:cervicothoracic junction mobilization

EXPERIMENTAL

Group A: patients will receive cervicothoracic junction mobilization and conventional physical therapy program for 3 sessions/week over 4 weeks periods

Other: cervicothoracic junction mobilization in form of Maitland mobilizationOther: conventional physical therapy

Group B:autogenic muscle Energy Technique

EXPERIMENTAL

Group B: will receive autogenic muscle Energy Technique and conventional physical therapy program for 3 sessions/week over 4 weeks periods.

Other: autogenic muscle Energy TechniqueOther: conventional physical therapy

Group C:conventional physical therapy

ACTIVE COMPARATOR

Group C: will receive conventional physical therapy only in form of: (superficial heat using hot pack for 10 minutes , Isometric Neck Exercises and Dynamic Neck Exercises)) for 3 sessions/week over 4 weeks periods.

Other: conventional physical therapy

Interventions

Group A: will receive cervicothoracic junction mobilization mobilization in form of Maitland mobilization to the C7-T1 level, according to their primary movement restriction (for flexion-extension restriction- central PA glide, for rotation restrictions (unilateral PA glide) for 3 sessions/week over 4 weeks periods.

Group A:cervicothoracic junction mobilization

the technique will applied to neck muscles that are prone to get short including anterior, middle and posterior Scaleni, Sternocleidomastoid, Levator Scapulae and upper fibers of the Trapezius muscle. The AI MET group will given 3-5 repetitions of post isometric relaxation (PIR) (30-50% isometric contraction of the muscle to be stretched for 7-10 seconds, followed by rest period of 5 seconds and then a stretch of 10-60 seconds hold

Group B:autogenic muscle Energy Technique

conventional physical therapy only in form of: (superficial heat using hot pack for 10 minutes , Isometric Neck Exercises and Dynamic Neck Exercises)) for 3 sessions/week over 4 weeks periods

Group A:cervicothoracic junction mobilizationGroup B:autogenic muscle Energy TechniqueGroup C:conventional physical therapy

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with a primary complaint of chronic neck pain (assessed by VAS )for more than 3 months
  • Subjects with pain provocation and reduced mobility at the CT junction segment (assessed by passive accessory intervertebral movements (PAIVMs) and reduced mobility at cervical spine (assessed by CROM device.
  • patients with age range from 18 to 45 years old.
  • patients with body mass index less than 30 kg/m2.

You may not qualify if:

  • previous spine surgery
  • pregnancy.
  • Diabetic patients
  • Hypertensive patients
  • Patients were excluded if neck pain was associated with cervical radiculopathy
  • whiplash injuries or severe headaches
  • cervical spine fracture
  • vertebro-basilar insufficiency.
  • red flags suggesting of cancer, infection, vascular insufficiency
  • Rheumatologic condition as mild systemic lupus erythematosus, poly-articular osteoarthritis, rheumatoid arthritis and advanced cervical spine degenerative diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FACULTY OF PHYSICAL THERAPY, cairo university

Giza, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1. mobilization and conventional physical therapy 2. autogenic muscle Energy Technique and conventional physical therapy 3. conventional physical therapy only
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 24, 2022

First Posted

September 28, 2022

Study Start

November 1, 2022

Primary Completion

July 30, 2023

Study Completion

July 30, 2023

Last Updated

August 28, 2023

Record last verified: 2023-08

Locations