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

Overview

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.

Full Title of Study: “Effects of Autogenic and Reciprocal Inhibition Techniques With Conventional Therapy in Mechanical Neck Pain- A Randomized Control Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: March 31, 2022

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • 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)
  • 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 .

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dow University of Health Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mahrukh Siddiqi, Principal Investigator – Dow University of Health Sciences
  • Overall Official(s)
    • Mahrukh Siddiqi, MSAPT, Principal Investigator, Dow University of Health Sciences
    • Saeed Akhter, MSPT, Study Director, Dow University of Health Sciences
    • Aftab Ahmed Mirza Baig, MSAPT, Principal Investigator, Dow University of Health Sciences
  • Overall Contact(s)
    • Mahrukh Siddiqi, MSAPT, +923232117522, siddiqimaharukh@yahoo.com

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