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

Study Overview
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Brief Summary
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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.

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

Conditions
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Mechanical Neck Pain

Intervention / Treatment
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* Other: Autogenic Inhibition MET
* Other: Reciprocal Inhibition MET


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: It is a randomized control trial. Total 80 patients will be recruited, 40 in each group that includes 10 patients as a dropout in both groups. There will be one interventional group and one active comparator group. Treatment will be allocated using a random number sheet generated by statistician. Participants are assigned to one of two groups in parallel for the duration of the study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 (Autogenic Inhibition)<br>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<br>* If a sub-maximal contraction of the muscle is followed by stretching of the same muscle it is known as Autogenic Inhibition MET.<br>|
| Active Comparator: Group 2 (Reciprocal Inhibition)<br>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<br>* If a submaximal contraction of a muscle is followed by stretching of the opposite muscle then this is known as Reciprocal Inhibition MET.<br>|

What is the study measuring?
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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. | 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. | 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. | 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. | 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. | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neck Pain, Manual Therapies, Therapy-Soft Tissue, Muscle Stretching exercises