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V-sitting Posture Stabilization Versus Modified Clamshell in Patients With Non-specific Chronic Low Back Pain.

Primary Purpose

Non-specific Chronic Low Back Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
V-sitting posture stabilization
Modified clamshell exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-specific Chronic Low Back Pain focused on measuring low back pain, disability, pain intensity, chronic pain

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with non-specific low back pain for more than 3 months
  • Subjects being able to sustain 5 seconds of isometric hip abduction in the side-lying position
  • Negative Crossed Straight leg raise test
  • Negative Straight leg raise test

Exclusion Criteria:

  • Metabolic Bone disease (Osteoporosis)
  • Any History of Hip pathology
  • History of trauma
  • History of systemic disease (Rheumatologic disorders, spondylitis, spinal cord disease)
  • Radiculopathy

Sites / Locations

  • Riphah Rehabilitation Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

V-sitting posture stabilization

modified clamshell exercises

Arm Description

V sitting exercises will be administered where patients will be asked to lift the torso and legs while engaging the core and abdominal muscles.

Participants will perform modified clamshell exercises monitored visually and using a stabilizer pressure biofeedback unit.

Outcomes

Primary Outcome Measures

NPRS for pain
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
RMQ for pain and disability
The Roland-Morris Questionnaire (RMQ) is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale. For example, at the beginning of treatment, a patient's score was 12 and, at the conclusion of treatment, their score was 2 (10 points of improvement), we would calculate an 83% (10/12 x 100) improvement.

Secondary Outcome Measures

Full Information

First Posted
May 23, 2022
Last Updated
May 23, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05393336
Brief Title
V-sitting Posture Stabilization Versus Modified Clamshell in Patients With Non-specific Chronic Low Back Pain.
Official Title
Comparison of V-sitting Posture Stabilization and Modified Clamshell Exercises on Pain and Disability in Patients With Non-specific Chronic Low Back Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 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
The aim of this study is to compare the v-siting posture stabilization and clamshell exercises on pain and disability in patients with non-specific chronic low back pain.
Detailed Description
Chronic low back pain (LBP) is a common musculoskeletal pain disorder that affects most adults and has the highest prevalence among other chronic musculoskeletal pain disorders. Non-traumatic lower back pain can have different etiologies: intervertebral disc related, vertebral body related, and facet joint related and sacroiliac joint related. Non-specific low back pain affects people of all ages and is a leading contributor to disease burden worldwide. Non-specific low back pain does not have a known pathoanatomical cause. Treatment of non-specific chronic low back pain includes manual therapy, exercise therapy, massage, acupuncture, yoga, cognitive behavioral therapy, and intensive interdisciplinary treatment. Previous studies have compared the effects of different exercise therapies, other treatment modalities, osteopathic techniques, manual therapies, and yoga and eurhythmy therapy for the management of low back pain. There is very little literature found to evaluate the effects of single movement technique V-sitting exercises and modified clamshell exercises in the management of non-specific chronic low back pain. Previous literature showed less treatment sessions and follow up periods as they are barrier to see the exact picture of effects of treatment protocol followed. In contrast longer duration of treatment regime allow deep insight of the effects of the main treatment body. This study will fulfill these literature gaps. This study will find the comparative effects of V-sitting posture stabilization and Modified Clamshell exercises in the treatment of non-specific chronic low back pain with more treatment sessions in both genders.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-specific Chronic Low Back Pain
Keywords
low back pain, disability, pain intensity, chronic pain

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
V-sitting posture stabilization
Arm Type
Experimental
Arm Description
V sitting exercises will be administered where patients will be asked to lift the torso and legs while engaging the core and abdominal muscles.
Arm Title
modified clamshell exercises
Arm Type
Experimental
Arm Description
Participants will perform modified clamshell exercises monitored visually and using a stabilizer pressure biofeedback unit.
Intervention Type
Other
Intervention Name(s)
V-sitting posture stabilization
Intervention Description
15 patients will be given a hot pack with TENS for 15 minutes. Followed by static stretching of the gluteus, hamstrings, and Iliopsoas muscles for 10 to 30 seconds hold and 2 to 4 repetitions. Then the patient will perform the V-sitting exercise for 10 seconds starting with 5 repetitions and progressing to 15 overtime. Each patient will receive treatment for 6 days per week and 6 weeks.
Intervention Type
Other
Intervention Name(s)
Modified clamshell exercises
Intervention Description
15 patients will be given a hot pack with TENS for 15 minutes. Followed by static stretching of the gluteus, hamstrings, and Iliopsoas muscles for 10 to 30 seconds hold and 2 to 4 repetitions. Then the patient will perform the modified clamshell exercise for 10 seconds starting with 5 repetitions and progressing to 15 overtime. Each patient will receive treatment for 6 days per week and 6 weeks.
Primary Outcome Measure Information:
Title
NPRS for pain
Description
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Time Frame
6th week
Title
RMQ for pain and disability
Description
The Roland-Morris Questionnaire (RMQ) is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale. For example, at the beginning of treatment, a patient's score was 12 and, at the conclusion of treatment, their score was 2 (10 points of improvement), we would calculate an 83% (10/12 x 100) improvement.
Time Frame
6th week

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: Patients with non-specific low back pain for more than 3 months Subjects being able to sustain 5 seconds of isometric hip abduction in the side-lying position Negative Crossed Straight leg raise test Negative Straight leg raise test Exclusion Criteria: Metabolic Bone disease (Osteoporosis) Any History of Hip pathology History of trauma History of systemic disease (Rheumatologic disorders, spondylitis, spinal cord disease) Radiculopathy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, PhD
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Salman Bashir, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah Rehabilitation Clinic
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Salman Bashir, PhD
Phone
+923334497959
Email
salman.bashir@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Muhammad Ahmed Saleemi

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34827088
Citation
Kwok BC, Lim JXL, Kong PW. The Theoretical Framework of the Clinical Pilates Exercise Method in Managing Non-Specific Chronic Low Back Pain: A Narrative Review. Biology (Basel). 2021 Oct 25;10(11):1096. doi: 10.3390/biology10111096.
Results Reference
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PubMed Identifier
33346210
Citation
Cho JH, Lee KH, Lim ST. Aged Lumbar Extension Strength of Chronic Low Back Pain in Korean Population of 10-80 Years. Iran J Public Health. 2020 Oct;49(10):1894-1901. doi: 10.18502/ijph.v49i10.4692.
Results Reference
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PubMed Identifier
32035569
Citation
Popescu A, Lee H. Neck Pain and Lower Back Pain. Med Clin North Am. 2020 Mar;104(2):279-292. doi: 10.1016/j.mcna.2019.11.003. Epub 2019 Dec 20.
Results Reference
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PubMed Identifier
31151341
Citation
Clark JR, Nijs J, Smart K, Holmes P, Yeowell G, Goodwin PC. Prevalence of Extreme Trait Sensory Profiles and Personality Types in Nonspecific Chronic Low Back Pain with Predominant Central Sensitization: Secondary Analysis of an International Observational Study. Pain Physician. 2019 May;22(3):E181-E190.
Results Reference
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PubMed Identifier
33785233
Citation
Tanabe H, Akai M, Doi T, Arai S, Fujino K, Hayashi K; for Low back-pain Traction Therapy (LTT) Study. Immediate effect of mechanical lumbar traction in patients with chronic low back pain: A crossover, repeated measures, randomized controlled trial. J Orthop Sci. 2021 Nov;26(6):953-961. doi: 10.1016/j.jos.2020.09.018. Epub 2021 Mar 27.
Results Reference
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PubMed Identifier
33369625
Citation
van Dillen LR, Lanier VM, Steger-May K, Wallendorf M, Norton BJ, Civello JM, Czuppon SL, Francois SJ, Roles K, Lang CE. Effect of Motor Skill Training in Functional Activities vs Strength and Flexibility Exercise on Function in People With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Neurol. 2021 Apr 1;78(4):385-395. doi: 10.1001/jamaneurol.2020.4821. Erratum In: JAMA Neurol. 2021 Jan 19;:
Results Reference
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PubMed Identifier
33749637
Citation
Krause F, Niederer D, Banzer W, Vogt L. Medical exercise and physiotherapy modes and frequency as predictors for a recurrence of chronic non-specific low back pain. J Back Musculoskelet Rehabil. 2021;34(4):665-670. doi: 10.3233/BMR-200149.
Results Reference
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PubMed Identifier
33197571
Citation
Dal Farra F, Risio RG, Vismara L, Bergna A. Effectiveness of osteopathic interventions in chronic non-specific low back pain: A systematic review and meta-analysis. Complement Ther Med. 2021 Jan;56:102616. doi: 10.1016/j.ctim.2020.102616. Epub 2020 Nov 13.
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Citation
Sanchis-Sanchez E, Lluch-Girbes E, Guillart-Castells P, Georgieva S, Garcia-Molina P, Blasco JM. Effectiveness of mechanical diagnosis and therapy in patients with non-specific chronic low back pain: a literature review with meta-analysis. Braz J Phys Ther. 2021 Mar-Apr;25(2):117-134. doi: 10.1016/j.bjpt.2020.07.007. Epub 2020 Aug 4.
Results Reference
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V-sitting Posture Stabilization Versus Modified Clamshell in Patients With Non-specific Chronic Low Back Pain.

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