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Effects of Primal Reflex Release Technique in Chronic Non-specific Low Back Pain

Primary Purpose

Chronic Non-specific Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Control group (conventional therapy)
Primal Reflex release Technique
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Non-specific Low Back Pain focused on measuring Low Back pain, Disability, Flexibility, Primal Reflex, Autonomic Nervous system

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 25-45

  • Both males and females
  • Lower cross syndrome diagnosed by straight leg raise, modified Thomas test, piriformis stretch test.
  • History of LBP for more than 6 weeks before the study, or had on-and-off pain having suffered at least 3 episodes of LBP during the year before the study, each lasting more than a year
  • The diagnosis confirmed on the presence of -pain experienced between the costal margins and the inferior gluteal folds which is influenced by physical activities and postures, usually accompanied by painful limitation of motion‖

Exclusion Criteria:

No recent history of injury to lower limb

  • No experience with surgical treatments for disc herniation, spina bifida, or spinal stenosis,
  • No nerve root compression or no neurological problems.
  • SIJ compression test positive

Sites / Locations

  • Arif Memorial Teaching HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control group (conventional therapy)

Primal Reflex release Technique

Arm Description

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale
Patient level of pain will be evaluated by using the NPRS (0-10 with 0 representing -no pain‖ and 10 the -worst pain‖). Clinometric properties of the NPRS are well established .The NPRS minimal clinically important difference (MCID) is 2 points
Ronald Morris Disability Questionnaire
To measure the level of disability caused by CLBP, we will use the Ronald Morris disability questionnaire RMDQ (0-24, with 0 representing no disability and 24 the most disability), which has good internal consistency (Cronbach's alpha =0.83) and test-retest reliability (interclass correlation coefficient= 0.87). Its MCID varies between 1-2 points in patients with minimal disability and 7-8 points in patients with severe disability
Schober's Test
The schober's test will be used to assess flexibility in the lower back. Schober's test will be applied to assess spinal mobility, with participants standing at maximal spinal flexion. The reference points will be near the fifth lumbar vertebra (between the posterior superior iliac spines) and 10 cm above this point. The test will be considered normal when there is difference of five or more centimeters between standing upright and at maximal spinal flexion
Ankle Knee Extension Test
The Ankle knee extension test (TTT) will be used to measure hamstring muscle flexibility. In this test, each subject will be in supine position, with a small pillow beneath his head and neck. The knee flexion axis will be marked by a pen and from this point, a line will be drawn to the greater trochanter of the femur and one other line to the external malleolus of the ankle. These lines will be used to measure knee joint angles. The goniometer axis will be on the knee axis and its arm will be along the line drawn on the thigh and the other arm will be along the line drawn on the leg. The subject will be asked to do the active knee extension slowly within 3 s as far as he/she could while the ankle remains in a neutral position. Then, when the active knee extension movement will complete and the subject will attempt to keep this situation for a second, the angle indicated by the goniometer will be extension angle of the knee joint
Modified Thomas Test
The modified Thomas test (MTT) will be used to measure Iliopsoas muscle flexibility
FAIR (Flexion Adduction internal rotation) Test
The flexion adduction internal rotation test (FAIRT) will be used to measure Piriformis muscle flexibility
Active Ankle Dorsiflexion Test
The Active Ankle Dorsiflexion will be used to measure gastrocnemius flexibility.

Secondary Outcome Measures

Patient Global Impression Of Change
The perception of improvement after treatment will be assessed by the patient global impression of change PGIC (range 0-7) (23). This scale is valid and recommended for patients with chronic pain

Full Information

First Posted
April 21, 2022
Last Updated
June 15, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05347368
Brief Title
Effects of Primal Reflex Release Technique in Chronic Non-specific Low Back Pain
Official Title
Effects of Primal Reflex Release Technique on Pain, Disability and Flexibility in Patients With Chronic Non-specific Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2022 (Actual)
Primary Completion Date
December 25, 2022 (Anticipated)
Study Completion Date
January 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

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

5. Study Description

Brief Summary
Low back pain is a major disorder which occurs from chronic over use and injury to lumbar musculoskeletal system. Sometimes the source of pain is non-specific leading to pain and spasm due to muscle imbalance. Primal reflex release technique is a novel concept to decrease pain and muscle spasm by resetting reflexes using reciprocal inhibition following the concept of rebooting the Autonomic nervous system. This study aims to determine the effects of primal reflex release technique on pain, flexibility and disability in chronic nonspecific low back pain patients. This study will be a Randomized Controlled trial and will be conducted at Arif Memorial Hospital in Lahore. A sample size of Total 32 patients will be taken in this study using consecutive sampling technique. Patients will be randomly assigned into two groups. Group A will be treated by conventional therapy and Group B will be treated by conventional therapy and primal reflex release technique. Numeric Pain Rating Scale and Ronald Morris Disability Questionnaire will be used to evaluate pain and disability respectively. Flexibility of low back, Iliopsoas, hamstring, Piriformis and gastrocnemius will be measured by schober's test, modified Thomas test, Active knee extension test, FAIR test and active dorsiflexion, respectively. The evaluation will be on day 1 as pretreatment values and at 2nd and 4th week as post treatment values respectively. The collected data will be analyzed on SPSS - 25.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Non-specific Low Back Pain
Keywords
Low Back pain, Disability, Flexibility, Primal Reflex, Autonomic Nervous system

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group (conventional therapy)
Arm Type
Other
Arm Title
Primal Reflex release Technique
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Control group (conventional therapy)
Intervention Description
Physical therapy will be performed using physical agent modality that include hot pack (15 min), and therapeutic exercises (5 repetition per set, 2 sets each session) therapeutic exercises include spinal extension exercise, prone hip extension exercise, posterior pelvic tilt, cat-camel exercise
Intervention Type
Other
Intervention Name(s)
Primal Reflex release Technique
Intervention Description
The SI/Lumbar release Iliopsoas release Piriformis release Hamstring release Gastrocnemius release
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
Patient level of pain will be evaluated by using the NPRS (0-10 with 0 representing -no pain‖ and 10 the -worst pain‖). Clinometric properties of the NPRS are well established .The NPRS minimal clinically important difference (MCID) is 2 points
Time Frame
4 week
Title
Ronald Morris Disability Questionnaire
Description
To measure the level of disability caused by CLBP, we will use the Ronald Morris disability questionnaire RMDQ (0-24, with 0 representing no disability and 24 the most disability), which has good internal consistency (Cronbach's alpha =0.83) and test-retest reliability (interclass correlation coefficient= 0.87). Its MCID varies between 1-2 points in patients with minimal disability and 7-8 points in patients with severe disability
Time Frame
4 weeks
Title
Schober's Test
Description
The schober's test will be used to assess flexibility in the lower back. Schober's test will be applied to assess spinal mobility, with participants standing at maximal spinal flexion. The reference points will be near the fifth lumbar vertebra (between the posterior superior iliac spines) and 10 cm above this point. The test will be considered normal when there is difference of five or more centimeters between standing upright and at maximal spinal flexion
Time Frame
4 weeks
Title
Ankle Knee Extension Test
Description
The Ankle knee extension test (TTT) will be used to measure hamstring muscle flexibility. In this test, each subject will be in supine position, with a small pillow beneath his head and neck. The knee flexion axis will be marked by a pen and from this point, a line will be drawn to the greater trochanter of the femur and one other line to the external malleolus of the ankle. These lines will be used to measure knee joint angles. The goniometer axis will be on the knee axis and its arm will be along the line drawn on the thigh and the other arm will be along the line drawn on the leg. The subject will be asked to do the active knee extension slowly within 3 s as far as he/she could while the ankle remains in a neutral position. Then, when the active knee extension movement will complete and the subject will attempt to keep this situation for a second, the angle indicated by the goniometer will be extension angle of the knee joint
Time Frame
4 weeks
Title
Modified Thomas Test
Description
The modified Thomas test (MTT) will be used to measure Iliopsoas muscle flexibility
Time Frame
4 weeks
Title
FAIR (Flexion Adduction internal rotation) Test
Description
The flexion adduction internal rotation test (FAIRT) will be used to measure Piriformis muscle flexibility
Time Frame
4 weeks
Title
Active Ankle Dorsiflexion Test
Description
The Active Ankle Dorsiflexion will be used to measure gastrocnemius flexibility.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Patient Global Impression Of Change
Description
The perception of improvement after treatment will be assessed by the patient global impression of change PGIC (range 0-7) (23). This scale is valid and recommended for patients with chronic pain
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 25-45 Both males and females Lower cross syndrome diagnosed by straight leg raise, modified Thomas test, piriformis stretch test. History of LBP for more than 6 weeks before the study, or had on-and-off pain having suffered at least 3 episodes of LBP during the year before the study, each lasting more than a year The diagnosis confirmed on the presence of -pain experienced between the costal margins and the inferior gluteal folds which is influenced by physical activities and postures, usually accompanied by painful limitation of motion‖ Exclusion Criteria: No recent history of injury to lower limb No experience with surgical treatments for disc herniation, spina bifida, or spinal stenosis, No nerve root compression or no neurological problems. SIJ compression test positive
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Saima Zahid, PhD*
Phone
03334349520
Email
Saima.zahid@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saima Zahid, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arif Memorial Teaching Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saima Zahid, PhD*
Phone
03334349520
Email
saima.zahid@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Aleena Waheed, MSPT-OM

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Citation
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Effects of Primal Reflex Release Technique in Chronic Non-specific Low Back Pain

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