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

October 24, 2023 updated by: Yeditepe University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Ataşehir
      • Istanbul, Ataşehir, Turkey
        • Yeditepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  • 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.

Exclusion criteria

  • Pregnancy.
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: Real-time synchronized telerehabilitation program (STP).
patient education, core stabilization exercises, strengthening exercises, stretching exercises
Experimental: Pre-recording non-synchronized telerehabilitation program (NSTP)
Subjects in this group will receive their therapeutic exercises through instructional videos sent via Email or WhatsAPP.
Other: Pre-recording non-synchronized telerehabilitation program (NSTP)
Pre-recording non-synchronized telerehabilitation program (NSTP)
Other: Home non-supervised control group (HCG)
Minimum intervention which is a PDF file containing the same exercises with no follow ups.
Other: Home non-supervised control group (HCG)
Home non-supervised control group (HCG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: 12 weeks
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Roland Morris Disability Questionnaire
Time Frame: 12 weeks

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.
12 weeks
Oswestry Disability Index
Time Frame: 12 weeks

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.
12 weeks
Tampa Scale for Kinesiophobia
Time Frame: 12 weeks
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
12 weeks
SF-12 Health Questionnaire
Time Frame: 12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yeditepe University

Investigators

  • Study Chair: Elif Tuğçe ÇİL, Dr, Yeditepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

September 19, 2023

First Submitted That Met QC Criteria

October 24, 2023

First Posted (Actual)

October 25, 2023

Study Record Updates

Last Update Posted (Actual)

October 25, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Yeditepe2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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