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

Primary Purpose

Chronic Non-specific Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Real-time synchronized telerehabilitation program (STP).
Pre-recording non-synchronized telerehabilitation program (NSTP)
Home non-supervised control group (HCG)
Sponsored by
Yeditepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Non-specific Low Back Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yeditepe University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Real-time synchronized telerehabilitation program (STP).

Pre-recording non-synchronized telerehabilitation program (NSTP)

Home non-supervised control group (HCG)

Arm Description

Subjects in this group will have face to face real-time video tele-habilitation sessions twice a week using Zoom

Subjects in this group will receive their therapeutic exercises through instructional videos sent via Email or WhatsAPP.

Minimum intervention which is a PDF file containing the same exercises with no follow ups.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
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.

Full Information

First Posted
September 19, 2023
Last Updated
October 24, 2023
Sponsor
Yeditepe University
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1. Study Identification

Unique Protocol Identification Number
NCT06099470
Brief Title
Investigation of the Effects of Telerehabilitation Groups for Chronic Non-specific Low Back Pain.
Official Title
Investigation of the Effects of Synchronized and Non-synchronized Telerehabilitation Programs in the Management of Chronic Non-specific Low Back Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
September 1, 2023 (Actual)
Study Completion Date
September 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yeditepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
This study is a randomized control trial with two intervention groups and one control group with total sample size of 72: Real-time synchronized telerehabilitation program (STP). (n=24) Pre-recording non-synchronized telerehabilitation program (NSTP). (n=24) 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. 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. 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. 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): 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Non-specific Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Real-time synchronized telerehabilitation program (STP).
Arm Type
Experimental
Arm Description
Subjects in this group will have face to face real-time video tele-habilitation sessions twice a week using Zoom
Arm Title
Pre-recording non-synchronized telerehabilitation program (NSTP)
Arm Type
Experimental
Arm Description
Subjects in this group will receive their therapeutic exercises through instructional videos sent via Email or WhatsAPP.
Arm Title
Home non-supervised control group (HCG)
Arm Type
Other
Arm Description
Minimum intervention which is a PDF file containing the same exercises with no follow ups.
Intervention Type
Other
Intervention Name(s)
Real-time synchronized telerehabilitation program (STP).
Intervention Description
patient education, core stabilization exercises, strengthening exercises, stretching exercises
Intervention Type
Other
Intervention Name(s)
Pre-recording non-synchronized telerehabilitation program (NSTP)
Intervention Description
Pre-recording non-synchronized telerehabilitation program (NSTP)
Intervention Type
Other
Intervention Name(s)
Home non-supervised control group (HCG)
Intervention Description
Home non-supervised control group (HCG)
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Roland Morris Disability Questionnaire
Description
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.
Time Frame
12 weeks
Title
Oswestry Disability Index
Description
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.
Time Frame
12 weeks
Title
Tampa Scale for Kinesiophobia
Description
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
Time Frame
12 weeks
Title
SF-12 Health Questionnaire
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Tuğçe ÇİL, Dr
Organizational Affiliation
Yeditepe University
Official's Role
Study Chair
Facility Information:
Facility Name
Yeditepe University
City
Istanbul
State/Province
Ataşehir
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21982256
Citation
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Citation
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, Avon). 2020 Mar;73:17-27. doi: 10.1016/j.clinbiomech.2019.12.028. Epub 2020 Jan 3.
Results Reference
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Investigation of the Effects of Telerehabilitation Groups for Chronic Non-specific Low Back Pain.

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