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Comparison of MET and AIS on Erector Spinae Muscle in Low Back Pain

Primary Purpose

Mechanical Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Muscle Energy Technique
Active Isolated Stretching
Conventional Treatment
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mechanical Low Back Pain focused on measuring Active Isolated Stretching, Muscle Energy Technique, Mechanical Low Back Pain

Eligibility Criteria

35 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients having acute mechanical LBP.
  • Patients having restricted ROM.

Exclusion Criteria:

  • Patients with ankylosing spondylitis.
  • Patient undergone any spinal surgery.
  • Patient having scoliosis.
  • Patient with tumor.
  • Patient with Rheumatoid Arthritis and other systemic diseases.
  • Immobile/ Bed ridden patients.
  • Patients with cognitive Problems. 8. Patients having vertebral compression fracture. 9. Patients with slump test positive.

Sites / Locations

  • Riphah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A (MET)

Group B (AIS)

Arm Description

Muscle Energy Technique Conventional Treatment

Active Isolated Stretching Conventional Treatment

Outcomes

Primary Outcome Measures

Erector Spinae Muscle Length through Measuring Tape
The length of the erector spinae can be evaluated in seated position with the legs fully flexed off the end of the table. The therapist stands behind the patient and palpates the anterior superior iliac spine (ASIS) bilaterally. The patient was taught and instructed to perform a posterior pelvic tilt, thus flattening the lumbar lordosis by creating lumbar flexion. Then, the patient was instructed to flex forward, attempting to bring the forehead to the knees. The practitioner feels for when the ASIS of the patient begins to move, which would indicate the end of thoracolumbar flexion and would indicate the initiation of an anterior pelvic tilt. Patient's forehead should come within 10 inches of the knees. The therapist had to note that no knee flexion occurred and the movement is coming from the thoracolumbar spine only. In the current study, erector spinae muscle length was measured prior starting the treatment as well as after completing the last treatment session.
Oswestry Disability Index (ODI)
ODI is the tool to measure the level of disability in essential conditions. This scale totally focuses on the evaluation of disability and impairment caused due to LBP. It contains 10 questions which are easily understandable. The very first question in the questionnaire is about the intensity of pain while next questions are about the level of disability and impairment caused on activity of daily living (ADLs) which includes "sleep, lifting, walking, sex life, sitting and so forth." Score for each question is from zero, which indicates no intensity, to five which indicates greatest inability due to LBP. Total obtained score of ten questions was calculated which was divided by the total possible score (i.e., 50) and then it was multiplied by hundred. The answer was in percentage. Let's assume, the total score of the patient was 20 and total possible score is 50 then 20/50 x 100 = 40 %.
Numeric Pain Rating Scale (NPRS)
NPRS is a tool to measure the pain intensity. Frequently, pain is the main concern of the patient which compelled him/ her to pursue treatment and NPRS is essential tool to gauge pain intensity in routine practice although psychological aspects of pain can also be considered. NPRS contains eleven levels from zero, which presents "no pain", till ten which presents the "worst pain" one can feel, as shown in figure 11. NPRS is an exceptionally easy to quantify pain, can be used by the patient him self and even it can likewise be utilized in people with low proficiency. It is utilized routinely in numerous nations and languages.

Secondary Outcome Measures

Lumbar Spine ROM through Inclinometer
Lumbar spine range of motion was performed in standing position with help of "inclinometer". The "American Medical Association" issued the guidelines in which the use of inclinometers has been declared as "a feasible and potentially accurate method of measuring spine mobility." In current study, dual- inclinometer method was used to measure the lumbar spine ROM of "flexion, extension, right and left side bending" prior starting the treatment as well as after completing the last treatment session. Diseases of lumbar spine, spinal muscular issues reduce the lumbar spine ROM. ROM values for normal lumbar spine. Patient was in standing position. Baseline inclinometer was placed on the "midline of spine in line with Posterior superior iliac spine (PSIS)" and superior inclinometer was placed "15 cm above baseline landmark". Patient was asked to flex the spine as much as he/she can. Inclinometers was placed in above mentioned points by the therapist till the end of possible ROM.

Full Information

First Posted
November 6, 2019
Last Updated
January 8, 2020
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04156776
Brief Title
Comparison of MET and AIS on Erector Spinae Muscle in Low Back Pain
Official Title
Comparison Of Muscle Energy Technique And Active Isolated Stretching On Erector Spinae Muscle In The Management Of Mechanical Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 12, 2018 (Actual)
Primary Completion Date
December 10, 2018 (Actual)
Study Completion Date
February 25, 2019 (Actual)

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
Yes

5. Study Description

Brief Summary
The main objective of the study was to compare the effectiveness of Muscle Energy Technique and Active Isolated Stretching on Erector Spinae Muscle in the management of Mechanical Low back Pain (LBP) and to find out that which technique is better for the treatment of mechanical LBP
Detailed Description
Lumbar spine "mobilization and manipulation" relieves the hypomobility in the intervertebral joints which results in pain reduction and significant improvement in lumbar spine ROMs. In dry needling, trigger point is palpated and tiny needle is inserted in hyperirritable point. Local twitch response is noted. Referred pain pattern may appear followed by pain relief and trigger point release. In this technique, pain is relieved by spontaneous positioning and maintains a non-painful tension in hypertonic muscle. When subject is placed in a non-tension position pain is decreased up to 70%. In Instrument assisted soft tissue mobilization: Various instruments like beveled edges,tools are used for soft tissue mobilization and decreasing pain threshold. MUSCLE ENERGY TECHNIQUE (MET) is actually a sort of "myofascial release soft-tissue method" in which the patient is given a command to use the muscles actively in a direction opposite to the force applied by the therapist which results in the enhancement of joint ROM and flexibility. In MET, "sub-maximal active resisted isometric contraction of muscle" is performed for couple of times after that the muscle is stretched passively which results in the increment in ROM, desired muscular length and flexibility. The concept which is used in MET is the reciprocal inhibition in which "the muscle which is faulty placed in mid range and the practitioner resists the greatest power either isotonically or isometrically". The patient is instructed to breathe in with the application of force and breathe out as the muscle is being lengthened For convenience, therapeutic exercises and specialized manual therapy treatment protocols can be divided into two main levels although the treatment of LBP depends on the condition of patient, intensity of pain, diagnosis and signs and symptoms. First level includes therapeutic exercises like "Range of Motion (ROM) exercises, stretching exercises, strengthening exercises and aerobic exercises" whereas second level includes advances manual therapy treatment protocols which includes specialised techniques like dry needling, strain counter strain, , lumbar stabilization exercises, MET, AIS etc When patient performs the exercises actively, nutritional supply gets enhanced to the soft tissues in lower back which keeps the vertebras, muscles, joints and ligaments sound. Lower back exercises keep the patient's spine healthy by maintaining its flexibility and strength and additionally, they decrease the chances of re-occurrence of LBP. Most commonly advised back exercises by physical therapists in the management of low back pain are "aerobic conditioning, stretching exercises, and strengthening exercises, McKenzie Exercises and lumbar stabilization exercises Lower back stretching exercises increase ROM and improves flexibility. Literature also recommends to stretch "hamstrings, piriformis and gluteal muscles" once or twice a day. Stretching exercises includes hamstring stretch or straight leg raising (SLR), knee to chest stretch, piriformis muscle stretch, etc Lower back stretching exercises increase ROM and improves flexibility. Literature also recommends to stretch "hamstrings, piriformis and gluteal muscles" once or twice a day. Stretching exercises includes hamstring stretch or SLR, knee to chest stretch, piriformis muscle stretch, etc On alternate days, doing aerobic exercises for 30 to 40 minutes a day for three times in a week, helps in the long-term reduction of LBP because by these exercises, nutrition supply can be enhanced to the soft tissues which promotes healing. Such type of exercises includes "walking, jogging, bicycling, swimming, etc Mobilization of lumbar spine, electrotherapy treatment, Stretching and strengthening exercises, postural correction of the individuals which are suffering from LBP are routine treatment protocols. Conventional physical therapy treatment is effective as it decreases the pain and improves the patient's functional outcome for patients of chronic LBP, but erector spinae muscle length remains compromised. Muscle energy technique and Active isolated stretching technique are advanced treatment protocols for getting improvement in muscle length by which patients get better in few sessions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Low Back Pain
Keywords
Active Isolated Stretching, Muscle Energy Technique, Mechanical Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group A (MET) and Group B (AIS)
Masking
Participant
Masking Description
Patients were not aware about the groups
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (MET)
Arm Type
Experimental
Arm Description
Muscle Energy Technique Conventional Treatment
Arm Title
Group B (AIS)
Arm Type
Experimental
Arm Description
Active Isolated Stretching Conventional Treatment
Intervention Type
Other
Intervention Name(s)
Muscle Energy Technique
Intervention Description
Muscle energy technique was repeated 4 times per session every day for 3 days a week for 4 weeks after the application of moist heating pad for 30 minutes before each session.
Intervention Type
Other
Intervention Name(s)
Active Isolated Stretching
Intervention Description
The patient was asked to sit in an upright seated position and flex his/her knees 12 to 18 inches. Patient was asked to tuck the chin, exhale, and firmly contract the abdominal muscles as he/she curls their body forward. He/she was also guided not to bounce or make rapid movements at the end range of the active motion. Then, he was asked to move back to the starting position and repeat the same procedure for 8 to 10 times. Stretch on the end range was not more than 2 seconds. This technique was repeated 10 times per session every day for 3 days a week for 4 weeks after the application of moist heating pad for 30 minutes before each session.
Intervention Type
Other
Intervention Name(s)
Conventional Treatment
Intervention Description
Conventional physical therapy treatment includes the application of moist heating pad for 30 minutes on lower back/ lumbar region prior to the intervention to both groups.
Primary Outcome Measure Information:
Title
Erector Spinae Muscle Length through Measuring Tape
Description
The length of the erector spinae can be evaluated in seated position with the legs fully flexed off the end of the table. The therapist stands behind the patient and palpates the anterior superior iliac spine (ASIS) bilaterally. The patient was taught and instructed to perform a posterior pelvic tilt, thus flattening the lumbar lordosis by creating lumbar flexion. Then, the patient was instructed to flex forward, attempting to bring the forehead to the knees. The practitioner feels for when the ASIS of the patient begins to move, which would indicate the end of thoracolumbar flexion and would indicate the initiation of an anterior pelvic tilt. Patient's forehead should come within 10 inches of the knees. The therapist had to note that no knee flexion occurred and the movement is coming from the thoracolumbar spine only. In the current study, erector spinae muscle length was measured prior starting the treatment as well as after completing the last treatment session.
Time Frame
4th week
Title
Oswestry Disability Index (ODI)
Description
ODI is the tool to measure the level of disability in essential conditions. This scale totally focuses on the evaluation of disability and impairment caused due to LBP. It contains 10 questions which are easily understandable. The very first question in the questionnaire is about the intensity of pain while next questions are about the level of disability and impairment caused on activity of daily living (ADLs) which includes "sleep, lifting, walking, sex life, sitting and so forth." Score for each question is from zero, which indicates no intensity, to five which indicates greatest inability due to LBP. Total obtained score of ten questions was calculated which was divided by the total possible score (i.e., 50) and then it was multiplied by hundred. The answer was in percentage. Let's assume, the total score of the patient was 20 and total possible score is 50 then 20/50 x 100 = 40 %.
Time Frame
4th week
Title
Numeric Pain Rating Scale (NPRS)
Description
NPRS is a tool to measure the pain intensity. Frequently, pain is the main concern of the patient which compelled him/ her to pursue treatment and NPRS is essential tool to gauge pain intensity in routine practice although psychological aspects of pain can also be considered. NPRS contains eleven levels from zero, which presents "no pain", till ten which presents the "worst pain" one can feel, as shown in figure 11. NPRS is an exceptionally easy to quantify pain, can be used by the patient him self and even it can likewise be utilized in people with low proficiency. It is utilized routinely in numerous nations and languages.
Time Frame
4th week
Secondary Outcome Measure Information:
Title
Lumbar Spine ROM through Inclinometer
Description
Lumbar spine range of motion was performed in standing position with help of "inclinometer". The "American Medical Association" issued the guidelines in which the use of inclinometers has been declared as "a feasible and potentially accurate method of measuring spine mobility." In current study, dual- inclinometer method was used to measure the lumbar spine ROM of "flexion, extension, right and left side bending" prior starting the treatment as well as after completing the last treatment session. Diseases of lumbar spine, spinal muscular issues reduce the lumbar spine ROM. ROM values for normal lumbar spine. Patient was in standing position. Baseline inclinometer was placed on the "midline of spine in line with Posterior superior iliac spine (PSIS)" and superior inclinometer was placed "15 cm above baseline landmark". Patient was asked to flex the spine as much as he/she can. Inclinometers was placed in above mentioned points by the therapist till the end of possible ROM.
Time Frame
4th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients having acute mechanical LBP. Patients having restricted ROM. Exclusion Criteria: Patients with ankylosing spondylitis. Patient undergone any spinal surgery. Patient having scoliosis. Patient with tumor. Patient with Rheumatoid Arthritis and other systemic diseases. Immobile/ Bed ridden patients. Patients with cognitive Problems. 8. Patients having vertebral compression fracture. 9. Patients with slump test positive.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdul Ghafoor Sajjad, Phd*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Islamabad
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
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Comparison of MET and AIS on Erector Spinae Muscle in Low Back Pain

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