Clinical trial NCT05393336: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Non-specific Chronic Low Back Pain
Keywords: low back pain
disability
pain intensity
chronic pain
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: NPRS for pain
timeFrame: 6th week
measure: RMQ for pain and disability
timeFrame: 6th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah Rehabilitation Clinic
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Salman Bashir, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.