Investigation of the Effects of Telerehabilitation Groups for Chronic Non-specific Low Back Pain.
NCT ID: NCT06099470
Last Updated: 2023-10-25
Study Results
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Basic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2023-06-01
2023-09-01
Brief Summary
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The parameters we want to study is pain, disability, fear of movement, and quality of life.
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Detailed Description
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1. Real-time synchronized telerehabilitation program (STP). (n=24)
2. Pre-recording non-synchronized telerehabilitation program (NSTP). (n=24)
3. Home non-supervised control group (HCG). (n=24)
Sample Size Calculation:
An adequate sample size was calculated using G\*power 3.1.9.7. Statistical test fixed effects one-way ANOVA, the probability for alpha error (α) at 0.05, large effect size f = 0.4, power = 0.8, and three groups. A total of 66 subjects was calculated as the minimum required sample size. In addition, based on previous studies a dropout rate was set at 10%. Hence, the total sample size was increased to 72. Therefore, each group will have 24 subjects (n=24).
Method:
Intervention:
The three groups received a video conference education session. The content of the session was anatomy and physiology of the musculoskeletal structure, and kinesiology of the lumbar region. In addition, they were educated about the principles of pain, possible causes for the CNLBP, and how to manage CNLBP (correct posture and life modifications).
Subjects in the STP and NSTP received the same exercises based on core stabilization and stretching but with different method.
1. STP group will benefit from individual exercise session through real-time video calls, where the therapist demonstrates the exercises, and monitor the patient throughout the session.
2. NSTP group will benefit from thoroughly instructional videos that describe every step of each exercise and will be followed up weekly through a video call to monitor compliance and answer questions.
3. HCG group will receive a PDF file that includes the same exercises with written instructions. However, no further interventions nor follow-ups will be available for the HCG.
Protocol:
The exercise protocol (table1) will be as follow with total duration of 44 minutes:
Warm-up (5 minutes): Head tilt, head rotation, shoulder circles, chest stretch, side bend, hip circles, torso twist, forward bend, Cat-cow.
Stabilization exercises (25 minutes):
1. Level one: Tabletop with single knee and hip flexion. 4-point kneeling with single leg stretch. Bridge. One leg stretch. Straight leg side lifts. Sit-ups with lumbar region fixed on the floor.
2. Level two: Tabletop with step knee and hip flexion. 4-point kneeling with single-leg rise. Bridge with leg stretch. One leg stretch with knee extension. Straight leg side lifts with contralateral adduction. Sit-ups reach wrists to the knees.
3. Level three: Tabletop with double knee and hip flexion. 4-point kneeling with contralateral arm and leg raise. Bridge with leg stretch and hold. One leg stretch hold and alternate knee extension. Straight leg side lifts adduct and hold. Sit-ups arms crossed over the chest.
* 10 repetitions, 10 seconds rest intervals, 3 sets. Cooldown and stretching exercises (14 minutes): quadriceps stretch, kneeling hip flexor stretch, sitting adductor stretch, seated hip and ITB stretch, gluteal stretch (in prone position), piriformis stretch, hamstring-gastrocnemius stretch with a band, abdominal stretch, bend forward stretch.
30 seconds hold for each exercise, 3 cycles.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Real-time synchronized telerehabilitation program (STP).
Subjects in this group will have face to face real-time video tele-habilitation sessions twice a week using Zoom
Real-time synchronized telerehabilitation program (STP).
patient education, core stabilization exercises, strengthening exercises, stretching exercises
Pre-recording non-synchronized telerehabilitation program (NSTP)
Subjects in this group will receive their therapeutic exercises through instructional videos sent via Email or WhatsAPP.
Pre-recording non-synchronized telerehabilitation program (NSTP)
Pre-recording non-synchronized telerehabilitation program (NSTP)
Home non-supervised control group (HCG)
Minimum intervention which is a PDF file containing the same exercises with no follow ups.
Home non-supervised control group (HCG)
Home non-supervised control group (HCG)
Interventions
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Real-time synchronized telerehabilitation program (STP).
patient education, core stabilization exercises, strengthening exercises, stretching exercises
Pre-recording non-synchronized telerehabilitation program (NSTP)
Pre-recording non-synchronized telerehabilitation program (NSTP)
Home non-supervised control group (HCG)
Home non-supervised control group (HCG)
Eligibility Criteria
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Inclusion Criteria
* VAS score of at least 4.
* Age between 18 and 65.
* Ability to perform exercises.
* Internet access.
Exclusion Criteria
* History of spinal surgery.
* History of spinal injury.
* Misalignment or specific condition in the lumbar region.
* Inflammatory joint diseases.
* Any neurological symptoms.
* Diagnosed osteoporosis.
* Spondylosis.
* Radiculopathy in the lumbar region.
* Having a current inflammation in the trunk, lumbar or pelvic region.
* Receiving physical therapy or other conventional therapy for LBP in the past 6 months.
* Regular practice for Pilates or other specific exercise programs in the last 6 months
18 Years
65 Years
ALL
No
Sponsors
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Yeditepe University
OTHER
Responsible Party
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Principal Investigators
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Elif Tuğçe ÇİL, Dr
Role: STUDY_CHAIR
Yeditepe University
Locations
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Yeditepe University
Istanbul, Ataşehir, Turkey (Türkiye)
Countries
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References
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Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.
Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11.
Sipaviciene S, Kliziene I. Effect of different exercise programs on non-specific chronic low back pain and disability in people who perform sedentary work. Clin Biomech (Bristol). 2020 Mar;73:17-27. doi: 10.1016/j.clinbiomech.2019.12.028. Epub 2020 Jan 3.
In TS, Jung JH, Jung KS, Cho HY. Effects of the Multidimensional Treatment on Pain, Disability, and Sitting Posture in Patients with Low Back Pain: A Randomized Controlled Trial. Pain Res Manag. 2021 Jun 30;2021:5581491. doi: 10.1155/2021/5581491. eCollection 2021.
Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.
Narouei S, Barati AH, Akuzawa H, Talebian S, Ghiasi F, Akbari A, Alizadeh MH. Effects of core stabilization exercises on thickness and activity of trunk and hip muscles in subjects with nonspecific chronic low back pain. J Bodyw Mov Ther. 2020 Oct;24(4):138-146. doi: 10.1016/j.jbmt.2020.06.026. Epub 2020 Jul 30.
Zhang Y, Tang S, Chen G, Liu Y. Chinese massage combined with core stability exercises for nonspecific low back pain: a randomized controlled trial. Complement Ther Med. 2015 Feb;23(1):1-6. doi: 10.1016/j.ctim.2014.12.005. Epub 2015 Jan 3.
Macedo LG, Maher CG, Latimer J, McAuley JH. Motor control exercise for persistent, nonspecific low back pain: a systematic review. Phys Ther. 2009 Jan;89(1):9-25. doi: 10.2522/ptj.20080103. Epub 2008 Dec 4.
Saragiotto BT, Maher CG, Yamato TP, Costa LO, Menezes Costa LC, Ostelo RW, Macedo LG. Motor control exercise for chronic non-specific low-back pain. Cochrane Database Syst Rev. 2016 Jan 8;2016(1):CD012004. doi: 10.1002/14651858.CD012004.
Paatelma M, Kilpikoski S, Simonen R, Heinonen A, Alen M, Videman T. Orthopaedic manual therapy, McKenzie method or advice only for low back pain in working adults: a randomized controlled trial with one year follow-up. J Rehabil Med. 2008 Nov;40(10):858-63. doi: 10.2340/16501977-0262.
Other Identifiers
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Yeditepe2023
Identifier Type: -
Identifier Source: org_study_id
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