Effects of Autogenic and Reciprocal Inhibition Techniques With Conventional Therapy in Mechanical Neck Pain

February 2, 2022 updated by: Mahrukh Siddiqi, Dow University of Health Sciences

Effects of Autogenic and Reciprocal Inhibition Techniques With Conventional Therapy in Mechanical Neck Pain- A Randomized Control Trial

The objective of this randomized control trial is to determine the effectiveness of Autogenic and Reciprocal Inhibition techniques with conventional therapy in mechanical neck pain to improve Pain, Range of Motion, and Functional Disability in long term. This study is being conducted at the Physiotherapy department of Sindh Institute of Physical Medicine and Rehabilitation, Karachi (former institute of Dow University of Health Sciences) among 80 patients with mechanical neck pain on the basis of non-probability purposive sample technique with screening for study criteria through a consultant physician (blinded) . After taking informed consent all participants will be randomly allocated in two groups through second researcher who is not involved in screening, baseline assessment and providing intervention. Group 1 will receive Autogenic Inhibition muscle energy technique (MET) with conventional therapy and Group 2 will receive Reciprocal inhibition MET with conventional therapy. A total of 12 sessions will be provided. Outcomes will be assessed at baseline, after 1st session, and at last session.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74200
        • Sindh Institue of Physical Medicine and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Moderate intensity (3.5-7.4cm) Pain on VAS
  • Limited or Painful Cervical ROM
  • Pain more than 4 weeks (sub-acute and chronic)
  • 20-50 years Age

Exclusion Criteria:

  • Any Symptom and sign of Radiculopathy and Myelopathy
  • Any neurological disease like Multiple Sclerosis, Parkinson or Stroke
  • Taking any Pain medication
  • Trigger Point of Upper Trapezius
  • Any fracture, surgical procedure, or trauma of the cervical spine
  • Any red flag or signs of serious pathology like rheumatic or inflammatory diseases, malignancy, infection, or vascular disease such as Vertebro-Basilar Insufficiency.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 (Autogenic Inhibition)
Autogenic Inhibition (5 reps, 10-sec hold, 5-sec rest in between each rep, 1 set, in all sessions) will be provided with the Conventional therapy including neck Isometric strengthening exercise (Neck Flexion, Extension, Both sides Rotation, and Neck Bending with each 5 rep, 10-sec hold, 1 set, in all sessions), Maitland Central posterio-anterior glide (Grade 1 and 2, 30 rep, 3 sets, in all sessions) and hot pack (10 minutes in all sessions on the back of the neck)
Other: Autogenic Inhibition MET
If a sub-maximal contraction of the muscle is followed by stretching of the same muscle it is known as Autogenic Inhibition MET.
Active Comparator: Group 2 (Reciprocal Inhibition)
Reciprocal Inhibition (5 reps, 10-sec hold, 5-sec rest in between each rep, 1 set, in all sessions) will be provided with the with same Conventional therapy as in group 1 .
Other: Reciprocal Inhibition MET
If a submaximal contraction of a muscle is followed by stretching of the opposite muscle then this is known as Reciprocal Inhibition MET.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in pain on the 10 centimetre Visual analogue scale (VAS-10cm) at first day.
Time Frame: Baseline and 1 day
The patient will asked to mark the pain Intensity on the line of 0-10cm that measures the level of pain. The 0 refers no pain and 10-cm refers excruciating pain as perceived as maximum.
Baseline and 1 day
Change from baseline in pain on the 10 centimetre Visual analogue scale (VAS-10cm) at 12 session.
Time Frame: Baseline and 3 weeks
The patient will asked to mark the pain Intensity on the line of 0-10cm that measures the level of pain. The 0 refers no pain and 10-cm refers excruciating pain as perceived as maximum
Baseline and 3 weeks
Change from baseline in disability on the Neck Disability Index (NDI) at first session.
Time Frame: Baseline and 1 day
This questionnaire has been designed to give information as to neck pain of patient has affected the ability to manage in everyday life. Patient will be asked to answer every section and mark in each section only the one box that most closely describes his or her problem. The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. Points summed to a total score.The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage. The 0 points or 0% means : no activity limitations, 50 points or 100% means complete activity limitation. A higher score indicates more patient-rated disability. It is available in both English and Urdu. Minimum Detectable Change (90% confidence): 5 points or 10% points.
Baseline and 1 day
Change from baseline in disability on the Neck Disability Index (NDI) at 12 sessions.
Time Frame: Baseline and 3 weeks
This questionnaire has been designed to give information as to neck pain of patient has affected the ability to manage in everyday life. Patient will be asked to answer every section and mark in each section only the one box that most closely describes his or her problem. The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. Points summed to a total score.The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage. The 0 points or 0% means : no activity limitations, 50 points or 100% means complete activity limitation. A higher score indicates more patient-rated disability. It is available in both English and Urdu. Minimum Detectable Change (90% confidence): 5 points or 10% points.
Baseline and 3 weeks
Change from baseline in Neck range of motion measured through Goniometer at first session.
Time Frame: Baseline and 1 day
It is an instrument that is used to measures the available Range of Motion around a joint in degrees. The investigator will appropriately place goniometer to measure the range of motions of neck (Flexion, extension, right and left lateral flexion and rotation). Lower the reading of goniometer suggests decreased in range of motion and vice versa.
Baseline and 1 day
Change from baseline in Neck range of motion measured through Goniometer at 12 session.
Time Frame: Baseline and 3 weeks
It is an instrument that is used to measures the available Range of Motion around a joint in degrees. The investigator will appropriately place goniometer to measure the range of motions of neck (Flexion, extension, right and left lateral flexion and rotation). Lower the reading of goniometer suggests decreased in range of motion and vice versa.
Baseline and 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dow University of Health Sciences

Investigators

  • Principal Investigator: Mahrukh Siddiqi, MSAPT, Dow University of Health Sciences
  • Study Director: Saeed Akhter, MSPT, Sindh Institute of Physical Medicine and Rehabilitation, Karachi, Pakistan
  • Principal Investigator: Aftab Ahmed Mirza Baig, MSAPT, Sindh Institute of Physical Medicine and Rehabilitation, Karachi, Pakistan.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

September 4, 2021

First Submitted That Met QC Criteria

September 4, 2021

First Posted (Actual)

September 14, 2021

Study Record Updates

Last Update Posted (Actual)

February 3, 2022

Last Update Submitted That Met QC Criteria

February 2, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSiddiqi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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