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

Sponsor
Yeditepe University (Other)
Overall Status
Completed
CT.gov ID
NCT06099470
Collaborator
(none)
72
Enrollment
1
Location
3
Arms
3
Actual Duration (Months)
23.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Real-time synchronized telerehabilitation program (STP).
  • Other: Pre-recording non-synchronized telerehabilitation program (NSTP)
  • Other: Home non-supervised control group (HCG)
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Investigation of the Effects of Synchronized and Non-synchronized Telerehabilitation Programs in the Management of Chronic Non-specific Low Back Pain.
Actual Study Start Date :
Jun 1, 2023
Actual Primary Completion Date :
Sep 1, 2023
Actual Study Completion Date :
Sep 1, 2023

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Visual Analog Scale [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.

Secondary Outcome Measures

  1. Roland Morris Disability Questionnaire [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.

  2. Oswestry Disability Index [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.

  3. Tampa Scale for Kinesiophobia [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

  4. SF-12 Health Questionnaire [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yeditepe University Istanbul Ataşehir Turkey

Sponsors and Collaborators

  • Yeditepe University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yeditepe University
ClinicalTrials.gov Identifier:
NCT06099470
Other Study ID Numbers:
  • Yeditepe2023
First Posted:
Oct 25, 2023
Last Update Posted:
Oct 25, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Back Pain
Low Back Pain

Study Results

No Results Posted as of Oct 25, 2023