Back to resultsManual Therapy/Exercises vs. Physiotherapy/Back School vs. Waiting List in Patients With Chronic Low Back Pain
Primary Purpose
Chronic Low-back Pain
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Manual Therapy/Exercises
Physiotherapy/Back School
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low-back Pain
Eligibility Criteria
Inclusion Criteria: pre-existing and specialist confirmed diagnosis of chronic low back pain for at least 3 months prior to inclusion Average pain intensity with at least 40 mm on the VAS from 0 to 100 mm and pain on at least 5 of 7 weekdays in the last 3 months. Exclusion criteria: Regular own exercise practice for the treatment of back pain (including yoga and other interventions) Invasive spinal procedures within the past 6 weeks or planned within the next 10 weeks Acute disc herniation (diagnosed within the last 3 months) Congenital deformities of the lumbar spine Rheumatoid arthritis Fibromyalgia Ankylosing spondylitis Severe comorbidities Pregnancy/lactation Current participation in another clinical trial
Sites / Locations
- Charite University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Manual Therapy/Exercises
Physiotherapy/Back School
Waiting List
Arm Description
Three individual therapy sessions and nine group sessions manual therapy/exercises of 60 min. duration under the guidance of a trained therapist.
Three individual therapy sessions and nine group sessions physiotherapy/back school of 60 min. duration under the guidance of a trained therapist.
Study arm 3 consists of a waiting list control group, combined with the offer to participate in one of the above mentioned interventions after 6 months.
Outcomes
Primary Outcome Measures
Change from baseline in average pain intensity in previous week
Intensity of pain in previous week as measured on a 100 mm visual analog scale (0-100).
Secondary Outcome Measures
Change from baseline for back pain specific disability
Use of standardized Roland Morris Disability Questionnaire (RMDQ) to assess back pain specific disability. The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Change from baseline in average pain intensity in previous week
Intensity of pain in previous week as measured on a 100 mm visual analog scale (0-100).
Change from baseline in pain bothersomeness in previous week
Bothersomeness in previous week as measured on a 100 mm visual analog scale (0-100).
Change from baseline in pain medication use in the previous week
Specific self-reported pain medication use in previous week.
Change from baseline for health related quality of life
Use of standardized Short Form 36 Health Survey (SF-36). The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Change from baseline for pain self-efficacy
Use of standardized Pain Self-Efficacy Questionnaire (PSEQ). The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Change from baseline for work productivity
Use standardized Work Productivity and Activity Impairment Questionnaire (WPAI) to assess employment status and productivity. The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Change from baseline for anxiety and depression
Use of standardized Hospital Anxiety and Depression Scale (HADS). The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Full Information
NCT ID
NCT05843149
First Posted
April 20, 2023
Last Updated
October 24, 2023
Sponsor
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT05843149
Brief Title
Manual Therapy/Exercises vs. Physiotherapy/Back School vs. Waiting List in Patients With Chronic Low Back Pain
Official Title
Manual Therapy/Exercises vs. Physiotherapy/Back School vs. Waiting List in Patients With Chronic Low Back Pain - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
Sponsor did not want to continue the study.
Study Start Date
May 2, 2023 (Actual)
Primary Completion Date
September 26, 2023 (Actual)
Study Completion Date
September 26, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A randomized controlled trial for patients with chronic low back pain with two treatment arms and one waiting list control group. Primary outcome is pain intensity on VAS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manual Therapy/Exercises
Arm Type
Experimental
Arm Description
Three individual therapy sessions and nine group sessions manual therapy/exercises of 60 min. duration under the guidance of a trained therapist.
Arm Title
Physiotherapy/Back School
Arm Type
Experimental
Arm Description
Three individual therapy sessions and nine group sessions physiotherapy/back school of 60 min. duration under the guidance of a trained therapist.
Arm Title
Waiting List
Arm Type
No Intervention
Arm Description
Study arm 3 consists of a waiting list control group, combined with the offer to participate in one of the above mentioned interventions after 6 months.
Intervention Type
Behavioral
Intervention Name(s)
Manual Therapy/Exercises
Intervention Description
Three individual therapy sessions and nine group sessions manual therapy/exercises of 60 min. duration under the guidance of a trained therapist.
Intervention Type
Behavioral
Intervention Name(s)
Physiotherapy/Back School
Intervention Description
Three individual therapy sessions and nine group sessions physiotherapy/back school of 60 min. duration under the guidance of a trained therapist.
Primary Outcome Measure Information:
Title
Change from baseline in average pain intensity in previous week
Description
Intensity of pain in previous week as measured on a 100 mm visual analog scale (0-100).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change from baseline for back pain specific disability
Description
Use of standardized Roland Morris Disability Questionnaire (RMDQ) to assess back pain specific disability. The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Time Frame
3 months, 6 months
Title
Change from baseline in average pain intensity in previous week
Description
Intensity of pain in previous week as measured on a 100 mm visual analog scale (0-100).
Time Frame
6 months
Title
Change from baseline in pain bothersomeness in previous week
Description
Bothersomeness in previous week as measured on a 100 mm visual analog scale (0-100).
Time Frame
3 months, 6 months
Title
Change from baseline in pain medication use in the previous week
Description
Specific self-reported pain medication use in previous week.
Time Frame
3 months, 6 months
Title
Change from baseline for health related quality of life
Description
Use of standardized Short Form 36 Health Survey (SF-36). The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Time Frame
3 months, 6 months
Title
Change from baseline for pain self-efficacy
Description
Use of standardized Pain Self-Efficacy Questionnaire (PSEQ). The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Time Frame
3 months, 6 months
Title
Change from baseline for work productivity
Description
Use standardized Work Productivity and Activity Impairment Questionnaire (WPAI) to assess employment status and productivity. The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Time Frame
3 months, 6 months
Title
Change from baseline for anxiety and depression
Description
Use of standardized Hospital Anxiety and Depression Scale (HADS). The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Time Frame
3 months, 6 months
Other Pre-specified Outcome Measures:
Title
Number of participants with adverse events as a measure of safety and treatment adherence
Description
Identify and assess self reported and unanticipated adverse events over the course of the study as a measure of safety and treatment adherence.
Time Frame
3 months, 6 months
Title
Treatment adherence (class/session attendance)
Description
Assess treatment adherence according to attendance during 12 week intervention period.
Time Frame
3 months, 6 months
Title
App via mobile phones
Description
Use of an mobile app to assess back pain intensity, pain medication, practice time
Time Frame
3 times daily within baseline and 6 months
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:
pre-existing and specialist confirmed diagnosis of chronic low back pain for at least 3 months prior to inclusion
Average pain intensity with at least 40 mm on the VAS from 0 to 100 mm and pain on at least 5 of 7 weekdays in the last 3 months.
Exclusion criteria:
Regular own exercise practice for the treatment of back pain (including yoga and other interventions)
Invasive spinal procedures within the past 6 weeks or planned within the next 10 weeks
Acute disc herniation (diagnosed within the last 3 months)
Congenital deformities of the lumbar spine
Rheumatoid arthritis
Fibromyalgia
Ankylosing spondylitis
Severe comorbidities
Pregnancy/lactation
Current participation in another clinical trial
Facility Information:
Facility Name
Charite University
City
Berlin
ZIP/Postal Code
14109
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Manual Therapy/Exercises vs. Physiotherapy/Back School vs. Waiting List in Patients With Chronic Low Back Pain
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