NCT05190328

Brief Summary

The study will be a randomized controlled trial. This study will be conducted in The University of Lahore Teaching Hospital, Lahore, Pakistan. A sample size of 86 will be randomly allocated into two experimental groups,(43 participants in each group), by using computer-generated random number list method. The participants randomly allocated into two experimental, group A will receive Muscle energy technique (METs) specifically, Post isometric relaxation technique for upper trapezius and levator scapulae muscles, 1 set of 5 repetitions and 10 seconds hold along with routine physical therapy as (Hot pack, transcutaneous electrical nerve stimulator, strengthening and stretching exercises). Experimental group B will be delivered Active Release Technique on both sides of levator scapulae and upper trapezius muscles 1 set of 5 repetitions along with routine physical therapy as (Hot pack, transcutaneous electrical nerve stimulator, strengthening and stretching exercises). Both experimental groups will receive twelve treatment sessions (3 sessions per week for 4 weeks)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 13, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

September 30, 2022

Status Verified

September 1, 2022

Enrollment Period

8 months

First QC Date

December 30, 2021

Last Update Submit

September 29, 2022

Conditions

Keywords

Upper Cross Syndrome

Outcome Measures

Primary Outcomes (3)

  • Numeric Pain Rating Scale

    The Numeric pain rating scale (NPRS) is self-reported and simple tool to measure level of pain. This is 11-point numeric scale in this scale the respondents will select the intensity of their pain ranging from 0-10, where 0 means no pain and 10 means severe pain

    4 weeks

  • Neck Disability Index (NDI) questionnaire

    The neck disability index (NDI) questionnaire is comprise of 10 items and is frequently used as a patient reported outcome measurement tool to evaluate the physical and functional capacity of an individual with cervical pain.Neck disability index is also used to evaluate the difference between pre and post treatment. Each section on NDI is scored on 0 to 5 rating in which 0 points or 0% means no pain or no activity limitation and 5 means worst imaginable pain or 50 points or 100% means complete activity limitation.

    4 weeks

  • Range of motion

    Universal Goniometer is a clinical and easily available tool which is commonly used by physiotherapist to document the available range of movement at certain joints.

    4 weeks

Study Arms (2)

Muscle Energy Technique

EXPERIMENTAL

Experimental: Muscle Energy Technique Post isometric relaxation: Patient will perform isometrics on upper trapezius and levator scapulae one by one. Each isometric contraction will be held for 10 seconds and then participants will be asked to relax the contraction with exhalation. This will be repeated five times in one session. Routine Physical Therapy including TENS, Hot Pack, Strengthening, and stretching exercises will also be delivered along with the Muscle energy technique.

Other: Muscle Energy Technique

Active Release Technique

EXPERIMENTAL

Experimental: Active Release Technique: The therapist will apply deep pressure on both sides of levator scapulae and upper trapezius muscles (over the area of tenderness) and the patient will be instructed to actively move the muscle from a shortened to lengthened position and thereby breaking adhesions.1 set of 5 repetitions in one session. Routine Physical Therapy including TENS, Hot Pack, Strengthening, and stretching exercises will also be delivered along with active release technique

Other: Active Release Technique

Interventions

Experimental: Muscle Energy Technique Post isometric relaxation: Patient will perform isometrics on upper trapezius and levator scapulae one by one. Each isometric contraction will be held for 10 seconds and then participants will be asked to relax the contraction with exhalation. This will be repeated five times in one session. Routine Physical Therapy including TENS, Hot Pack, Strengthening, and stretching exercises will also be delivered along with Muscle energy technique.

Muscle Energy Technique

Experimental: Active Release Technique: Therapist will apply deep pressure on both sides of levator scapulae and upper trapezius muscles (over the area of tenderness) and the patient is instructed to actively move the muscle from the shortened to a lengthened position and thereby breaking adhesions. 1 set of 5 repetitions in one session. Routine Physical Therapy including TENS, Hot Pack, Strengthening, and stretching exercises will also be delivered along with Active Release Technique.

Active Release Technique

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The diagnosed Upper cross syndrome patients aged 20-35 years will be included in this study
  • Both male and females will be included in this study.
  • Patients with pain of at least 3 points on NPRS.
  • The participants with neck disability of at least 10/50 on the Neck Disability Index (NDI) will be included in this study.

You may not qualify if:

  • Cervical radiculopathy or myelopathy.
  • History of trauma, whiplash injury, cervical instability or fractures in cervical spine.
  • Systemic illness i.e. cardiovascular disorders, respiratory disorders etc.
  • Inflammatory disease i.e. rheumatoid arthritis, ankylosing spondylitis, osteomyelitis.
  • Any pathology i.e. infection, osteoporosis, malignancy bony disease i.e. osteosarcoma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lahore Teaching Hospital

Lahore, Punjab Province, 55150, Pakistan

Location

Related Publications (5)

  • Karimian R, Rahnama N, Ghasemi G, Lenjannejadian S. Photogrammetric Analysis of Upper Cross Syndrome among Teachers and the Effects of National Academy of Sports Medicine Exercises with Ergonomic Intervention on the Syndrome. J Res Health Sci. 2019 Jul 3;19(3):e00450.

    PMID: 31586371BACKGROUND
  • Kang JI, Choi HH, Jeong DK, Choi H, Moon YJ, Park JS. Effect of scapular stabilization exercise on neck alignment and muscle activity in patients with forward head posture. J Phys Ther Sci. 2018 Jun;30(6):804-808. doi: 10.1589/jpts.30.804. Epub 2018 Jun 12.

    PMID: 29950768BACKGROUND
  • Kim JH, Lee HS, Park SW. Effects of the active release technique on pain and range of motion of patients with chronic neck pain. J Phys Ther Sci. 2015 Aug;27(8):2461-4. doi: 10.1589/jpts.27.2461. Epub 2015 Aug 21.

    PMID: 26357426BACKGROUND
  • Thomas E, Cavallaro AR, Mani D, Bianco A, Palma A. The efficacy of muscle energy techniques in symptomatic and asymptomatic subjects: a systematic review. Chiropr Man Therap. 2019 Aug 27;27:35. doi: 10.1186/s12998-019-0258-7. eCollection 2019.

    PMID: 31462989BACKGROUND
  • Gillani SN, Ain Q-, Rehman SU, Masood T. Effects of eccentric muscle energy technique versus static stretching exercises in the management of cervical dysfunction in upper cross syndrome: a randomized control trial. J Pak Med Assoc. 2020 Mar;70(3):394-398. doi: 10.5455/JPMA.300417.

    PMID: 32207413BACKGROUND

MeSH Terms

Conditions

Oculocerebral hypopigmentation syndrome type Preus

Study Officials

  • Anam Akram, MS-MSK*

    University of Lahore

    PRINCIPAL INVESTIGATOR

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
EFFECTS OF MUSCLE ENERGY TECHNIQUE VERSUS ACTIVE RELEASE TECHNIQUE ON PAIN, CERVICAL RANGE OF MOTION AND FUNCTIONAL DISABILITY IN PATIENTS WITH UPPER CROSS SYNDROME: A RANDOMIZED CONTROLLED TRIAL.

Study Record Dates

First Submitted

December 30, 2021

First Posted

January 13, 2022

Study Start

November 10, 2021

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

September 30, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations