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

Primary Purpose

Mechanical Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Autogenic Inhibition MET
Reciprocal Inhibition MET
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mechanical Neck Pain focused on measuring Neck Pain, Manual Therapies, Therapy-Soft Tissue, Muscle Stretching exercises

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sindh Institue of Physical Medicine and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1 (Autogenic Inhibition)

Group 2 (Reciprocal Inhibition)

Arm Description

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)

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 .

Outcomes

Primary Outcome Measures

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.
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
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 4, 2021
Last Updated
February 2, 2022
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05044078
Brief Title
Effects of Autogenic and Reciprocal Inhibition Techniques With Conventional Therapy in Mechanical Neck Pain
Official Title
Effects of Autogenic and Reciprocal Inhibition Techniques With Conventional Therapy in Mechanical Neck Pain- A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 28, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Neck Pain
Keywords
Neck Pain, Manual Therapies, Therapy-Soft Tissue, Muscle Stretching exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Outcomes assessor involved in the clinical trial will be prevented from having knowledge of the interventions assigned to individual participants.
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (Autogenic Inhibition)
Arm Type
Experimental
Arm Description
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)
Arm Title
Group 2 (Reciprocal Inhibition)
Arm Type
Active Comparator
Arm Description
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 .
Intervention Type
Other
Intervention Name(s)
Autogenic Inhibition MET
Intervention Description
If a sub-maximal contraction of the muscle is followed by stretching of the same muscle it is known as Autogenic Inhibition MET.
Intervention Type
Other
Intervention Name(s)
Reciprocal Inhibition MET
Intervention Description
If a submaximal contraction of a muscle is followed by stretching of the opposite muscle then this is known as Reciprocal Inhibition MET.
Primary Outcome Measure Information:
Title
Change from baseline in pain on the 10 centimetre Visual analogue scale (VAS-10cm) at first day.
Description
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.
Time Frame
Baseline and 1 day
Title
Change from baseline in pain on the 10 centimetre Visual analogue scale (VAS-10cm) at 12 session.
Description
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
Time Frame
Baseline and 3 weeks
Title
Change from baseline in disability on the Neck Disability Index (NDI) at first session.
Description
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.
Time Frame
Baseline and 1 day
Title
Change from baseline in disability on the Neck Disability Index (NDI) at 12 sessions.
Description
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.
Time Frame
Baseline and 3 weeks
Title
Change from baseline in Neck range of motion measured through Goniometer at first session.
Description
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.
Time Frame
Baseline and 1 day
Title
Change from baseline in Neck range of motion measured through Goniometer at 12 session.
Description
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.
Time Frame
Baseline and 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahrukh Siddiqi, MSAPT
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Saeed Akhter, MSPT
Organizational Affiliation
Sindh Institute of Physical Medicine and Rehabilitation, Karachi, Pakistan
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Aftab Ahmed Mirza Baig, MSAPT
Organizational Affiliation
Sindh Institute of Physical Medicine and Rehabilitation, Karachi, Pakistan.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sindh Institue of Physical Medicine and Rehabilitation
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74200
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
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Effects of Autogenic and Reciprocal Inhibition Techniques With Conventional Therapy in Mechanical Neck Pain

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