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Low back pain is a common condition affecting many individuals at some point in their lives. The prevalence of Non-specific low back pain (LBP) is between 4.2% and 19.6%, which is responsible for high treatment costs, sick leave, and individual suffering, in addition to being one of the main reasons for people to seek health care services. LBP prevalence increases linearly from the third decade of life on, until the 60 years of age, being more prevalent in women. This trial will be a prospective, parallel, double blinded, randomized, interventional clinical trial (comparing Myofascial Release and Joint Mobilization therapy). The patients will be screened by researcher and randomly allocated into either experimental groups. After recruitment, the person will be contacted for allocation so that randomization will be secured and concealed. The outcome measure tools for data quantification will be used i.e. Diagnostic Ultrasound Scanner to measure lumbar multifidus and transversus abdominis muscle thickness, pain pressure algometer to measure pain pressure sensitivity and Halo-digital inclinometer to measure range of motion of the lumbar region. A pilot study was done on a sample of 30 with 10 participants in each group. A sample of 84 participants (28 participants in each group) with an attrition rate of 12%, level of significance 5%, margin of error 20% was the output. Patients will be randomly allocated in 3 groups (Group A, Joint mobilization: Group B, Myofascial Release: Group C, both joint mobilization and myofascial release: Common treatment, Heating for 15 minutes). Each group will receive 4 sessions of treatment in 2 weeks' period on Day 1st day 4th, day 8th and day 12th.Data will be collected on Day 1st; Pre and post-treatment, Day 4th, Day 8th,Day 12th; post treatment and after 1 month. Data will be analyzed with SPSS version.26.
Study will be conducted in Al-Razi Healthcare and Riphah Rehabilitation Centre, Lahore, Pakistan. The duration of study will be 18 months after the approval of synopsis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GROUP A | Experimental | Joint mobilization |
|
| GROUP B | Experimental | Myofascial release |
|
| GROUP C | Experimental | Joint Mobilization & Myofascial release |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Joint mobilization | Other | Maitland Mobilization GIII and GIV i. PA Central and unilateral vertebral pressure ii.Transverse vertebral pressure iii. heating pad for 15 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ultrasonography for Muscle thickness | Interpretation will be done according to the images received after ultrasonography. Readings will be done 1st day, 4th,8th,12th,and after one month. | 1 month |
| Pain Pressure Algometer | Pai threshold will be measured by applying pain pressure algometer and readings will be measured.Readings will be done 1st day, 4th,8th,12th,and after one month. | 1 month |
| Digital Inclinometer for Range of motion | Instrument used for Range of motion.Readings will be done 1st day, 4th,8th,12th,and after one month. Normal Ranges: FLEXION : 0-60, EXTENSION: 0-25, LATERAL FLEXION: 0-25, ROTATION :0-18 | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric pain rating scale | 0= no pain 10 = worse pain Readings will be done 1st day, 4th,8th,12th,and after one month. | 1 month |
| Sit and Reach test | Excellent: >34-26 cm Good= 34-26 cm Above average: 32-23 Average: 29-20 Below average: 26-17 cm Poor: 23-14 cm V poor: < 21- <12 cm Readings will be done 1st day, 4th,8th,12th,and after one month. |
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Inclusion Criteria:
Patients between the ages of 20 to 50 years for non-specific low back pain diagnosed by researcher according to the non-specific low back pain criteria comprising of history and physical examination. Physical examination should be done in different positions as follows
Both male and female patients will be recruited.
Patient diagnosis based on clinical assessment and duration of pain.
People who have not received physical therapy application or exercise regimen for the past 3 months
Patients suffering with low back pain for less than 3 months. Severity of Pain should be 3 to 7 on NPRS will be included in the study.
Patients not received analgesics and Non-steroidal anti-inflammatory drugs for previous 1 week.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Syed Shakil ur Rehman, PhD | Riphah International University | Principal Investigator |
| Hafiz Muhammad Waseem Javaid, PhD* | Riphah International University | Principal Investigator |
| Muhammad Kashif, PhD | Riphah International University | Principal Investigator |
| Muhammad Salman Bashir, PhD | Riphah International University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al-Razi Healthcare | Lahore | Punjab Province | 54000 | Pakistan | ||
| Riphah Rehabilitation Centre |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000089803 | Myofascial Release Therapy |
| ID | Term |
|---|---|
| D008405 | Massage |
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
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| Myofascial Release | Other | Myofascial release is a hands-on soft tissue technique that facilitates a stretch into the restricted fascia. A sustained pressure is applied into the restricted tissue barrier; after 90-120 seconds the tissue will undergo histological length changes allowing the first release to be felt. The therapist will follow the release into a new tissue barrier and holds. After a few releases the tissue will become softer and more pliable. The middle point of the Lateral raphae of the Thoracolumbarfascia between the posterior musculofascial junction of the Transversus Abdominis will be identified by ultrasonography. Vertical manual pressure will be applied on the middle point of the thoracolumbarfascia for 1 min ii. heating pad for 15 minutes |
|
| Joint mobilization & Myofascial Release | Other | Maitland Mobilization GIII and GIV i. PA Central and unilateral vertebral pressure ii.Transverse vertebral pressure iii. heating pad for 15 minutes iv. Myofascial release is a hands-on soft tissue technique that facilitates a stretch into the restricted fascia. A sustained pressure is applied into the restricted tissue barrier; after 90-120 seconds the tissue will undergo histological length changes allowing the first release to be felt. The therapist will follow the release into a new tissue barrier and holds. After a few releases the tissue will become softer and more pliable. The middle point of the Lateral raphae of the Thoracolumbarfascia between the posterior musculofascial junction of the Transversus Abdominis will be identified by ultrasonography. Vertical manual pressure will be applied on the middle point of the thoracolumbarfascia for 1 min |
|
| 1 month |
| Lahore |
| Punjab Province |
| Pakistan |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |