NCT04679363

Brief Summary

Neck pain is one of the leading causes of musculoskeletal pain and disability in the world. Despite the prevalence, accompanying disabilities, low quality of life and economic burdens of mechanical neck pain, there is a gap in high quality evidence to effectively guide the conservative treatment of this patient population. Active release technique (ART) is a soft tissue technique that focuses on removal of adhesions that build up in muscle due to overuse. ART can be used as both, as a diagnostic and treatment technique. Limited literature is available on evaluation and treatment of neck pain by Active release technique in contrast to Post isometric release technique. This study fulfills this gap and will provide clinicians with an alternative treatment approach for mechanical 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
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 15, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2020

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2020

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

2 months

First QC Date

November 23, 2020

Last Update Submit

December 17, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Numeric Pain Rating scale

    The Numeric pain rating scale is a tool used for measurement of pain. The Numeric pain rating scale is a tool used for measurement of pain. It is 11-point scale from 0-10, 0 = no pain and 10 = most intense pain imaginable. Reliability for NPRS is ICC = 0.67.

    3 weeks

Secondary Outcomes (2)

  • Algometry

    3 weeks

  • Cervical Range of Motion

    3 weeks

Study Arms (2)

Active release technique group

EXPERIMENTAL

Active release technique group (ART group) will receive Oscillatory mobilization with active release technique. Treatment will be provided for 2 session/week for 3 weeks with 40 minutes/session. Patient will be assessed at baseline and after 3rd week of intervention.

Other: Active release technique

Post isometric relaxation group

EXPERIMENTAL

Post isometric relaxation group (PIR group) will receive Oscillatory mobilization with post isometric relaxation technique. Treatment will be provided for 2 session/week for 3 weeks with 40 minutes/session. Patient will be assessed at baseline and after 3rd week of intervention.

Other: Post isometric relaxation

Interventions

ART will be performed on upper trapezius and sternocleidomastoid, starting from 5 repetitions in 1st and 2nd week and progressing to 10 repetitions in 3rd week. ART will be performed in supine position with a pillow under knees. After the shortened area of the targeted muscle is identified, soft tissue mobilization with active movement and passive overpressure will be applied. The active movement in technique will be from shortened position of muscle to lengthened position.

Active release technique group

PIR will be performed on upper trapezius and sternocleidomastoid muscles, starting from 5 repetitions in 1st and 2nd week and progressing to 10 repetitions in 3rd week. The patient will be instructed to move the ear towards the shoulder of the affected side, against the resistance of the therapist's hands with minimum force (only 20% of their total force). The patient will be instructed to perform isometric contraction of the affected side along with inhalation and position for 10 seconds. Then the patient will exhale completely and relax. During this relaxation phase head and neck are taken further away from ipsilateral shoulder and ipsilateral shoulder is pushed downward until next restriction is met.

Post isometric relaxation group

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with diagnosed mechanical neck pain
  • Having NDI score of equal to or more than 10%
  • Patients having neck pain less than 8 on NPRS

You may not qualify if:

  • Patients having non-musculoskeletal injury
  • Patients with nerve root compression
  • Whiplash injuries
  • History of cervical or thoracic spine surgery
  • Patient on pain medication for neck pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University Institute of Rehabilitation Sciences.

Islamabad, Federal, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Marwa Asim, MS

CONTACT

Ehab Azim, MS, PhD*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
outcome assessor will be masked by withholding information related to group allocation from him
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2020

First Posted

December 22, 2020

Study Start

September 15, 2020

Primary Completion

November 25, 2020

Study Completion

December 15, 2020

Last Updated

December 22, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations