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Chronic Non-specific Low Back PainNCT06099470

Investigation of the Effects of Telerehabilitation Groups for Chronic Non-specific Low Back Pain.

A study testing Real-time synchronized telerehabilitation program (STP). and Pre-recording non-synchronized telerehabilitation program (NSTP) in people with Chronic Non-specific Low Back Pain, run by Yeditepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this study is to investigate the efficacy of different internet based delivery methods for patients with chronic non-specific low back pain. The parameters we want to study is pain, disability, fear of movement, and quality of life. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Non-specific Low Back Pain
What is being tested?
Real-time synchronized telerehabilitation program (STP). and Pre-recording non-synchronized telerehabilitation program (NSTP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2023to 1 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Persisting low back pain for the past 3 months.
  • VAS score of at least 4.
  • Age between 18 and 65.
  • Ability to perform exercises.
  • Internet access.

Who cannot join

  • Pregnancy.
  • History of spinal surgery.
  • History of spinal injury.
  • Misalignment or specific condition in the lumbar region.
  • Inflammatory joint diseases.
  • Any neurological symptoms.
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Yeditepe University

    Istanbul, Ataşehir

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Effects of Synchronized and Non-synchronized Telerehabilitation Programs in the Management of Chronic Non-specific Low Back Pain.

The goal of this study is to investigate the efficacy of different internet based delivery methods for patients with chronic non-specific low back pain.

The parameters we want to study is pain, disability, fear of movement, and quality of life.

Read the detailed description

This study is a randomized control trial with two intervention groups and one control group with total sample size of 72:

  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.
Being tested
Real-time synchronized telerehabilitation program (STP)., Pre-recording non-synchronized telerehabilitation program (NSTP), Home non-supervised control group (HCG)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Real-time synchronized telerehabilitation program (STP).Other

    patient education, core stabilization exercises, strengthening exercises, stretching exercises

  • Pre-recording non-synchronized telerehabilitation program (NSTP)Other

    Pre-recording non-synchronized telerehabilitation program (NSTP)

  • Home non-supervised control group (HCG)Other

    Home non-supervised control group (HCG)

Study groups in NCT06099470
Study groupRoleWhat they receive
Real-time synchronized telerehabilitation program (STP).ExperimentalSubjects in this group will have face to face real-time video tele-habilitation sessions twice a week using Zoom
Receives: Other: Real-time synchronized telerehabilitation program (STP).
Pre-recording non-synchronized telerehabilitation program (NSTP)ExperimentalSubjects in this group will receive their therapeutic exercises through instructional videos sent via Email or WhatsAPP.
Receives: Other: Pre-recording non-synchronized telerehabilitation program (NSTP)
Home non-supervised control group (HCG)OtherMinimum intervention which is a PDF file containing the same exercises with no follow ups.
Receives: Other: Home non-supervised control group (HCG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analog Scale

    is a visual scale with various types to measure the intensity of the pain where 0 is considered no pain and 10 is unbearable pain. VAS can be just a 100mm horizontal line where patients can put a mark anywhere on the line, or graphics indicating the severity of pain. Also, it can be numerical line from 0 to 10 which we intend to use in this thesis.

    Measured: 12 weeks

Secondary outcomes (4)
  1. Roland Morris Disability Questionnaire

    A sensitive and reliable evaluation tool, to measure disability in patients with chronic non-specific low back pain. It contains a 24-item scale with a total score ranging from 0 (no disability) to 24 (high disability). The questionnaire was prepared in the questionnaire was delivered electronically as checkboxes question on the prepared assessment google forms.

    Patients were asked to only choose the sentences that describes how they feel today and skip the sentences that does not.

    Measured: 12 weeks

  2. Oswestry Disability Index

    Is a gold standard, valid questionnaire, which assesses disability in ten distinct parts: pain intensity, patient personal care, lifting, walking, sitting, standing, sleeping, social life, sex life and travelling. Each statement is scored from 0 to 5 with higher scores demonstrating more disability. The questionnaire was prepared and delivered electronically as ten multiple choice questions on the prepared assessment google forms.

    Patients were asked to choose the part that most closely describes how they feel today.

    Measured: 12 weeks

  3. Tampa Scale for Kinesiophobia

    Tampa Scale for Kinesiophobia (TSK) was used. Which is a reliable 17-item scale to measure fear of movement and injury in patients with CNLBP. Each item ranges from 1 to 4 points, with 1 point for "total disagree," to 4 points for "total agree". The total score of the scale ranges from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia, and score ± 37 indicates there is kinesiophobia

    Measured: 12 weeks

  4. SF-12 Health Questionnaire

    SF-12 Health Questionnaire was used. Which is a questionnaire that measures the quality of life, by assessing the impact of health on everyday activities. It uses the same eight domains as the SF-36: limitations in physical activities because of health problems, limitations in social activities because of physical or emotional problems, limitations in usual role activities because of physical health problems, bodily pain, general mental health (psychological distress and well-being), limitations in usual role activities because of emotional problems, vitality (energy and fatigue), general health perceptions. The questionnaire was prepared and delivered electronically as 12 multiple choice questions on the prepared assessment google forms.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2023
  2. Study start1 Jun 2023
  3. Primary completion1 Sep 2023
  4. Study completion1 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06099470
Sponsor's protocol ID
Yeditepe2023
Status last verified
Sep 2023
First submitted
19 Sep 2023
Last updated
25 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21982256
  • 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.

    PubMed 27745712
  • 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.

    PubMed 31923778
  • 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.

    PubMed 34306274
  • 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.

    PubMed 29573870
  • 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.

    PubMed 33218502
  • 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.

    PubMed 25637146
  • 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.

    PubMed 19056854
  • 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.

    PubMed 26742533
  • 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.

    PubMed 19242624

Questions about this trial

What is this clinical trial studying?

A study testing Real-time synchronized telerehabilitation program (STP). and Pre-recording non-synchronized telerehabilitation program (NSTP) in people with Chronic Non-specific Low Back Pain, run by Yeditepe University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06099470, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.

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