Manual Therapy/Exercises vs. Physiotherapy/Back School vs. Waiting List in Patients With Chronic Low Back Pain

Manual Therapy/Exercises vs. Physiotherapy/Back School vs. Waiting List in Patients With Chronic Low Back Pain - a Randomized Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Behavioral: Manual Therapy/Exercises; Behavioral: Physiotherapy/Back School

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14109
    • Charité University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Manual Therapy/Exercises; Three individual therapy sessions and nine group sessions manual therapy/exercises of 60 min. duration under the guidance of a trained therapist.	Behavioral: Manual Therapy/Exercises; Three individual therapy sessions and nine group sessions manual therapy/exercises of 60 min. duration under the guidance of a trained therapist.
Experimental: Physiotherapy/Back School; Three individual therapy sessions and nine group sessions physiotherapy/back school of 60 min. duration under the guidance of a trained therapist.	Behavioral: Physiotherapy/Back School; Three individual therapy sessions and nine group sessions physiotherapy/back school of 60 min. duration under the guidance of a trained therapist.
No Intervention: Waiting List; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months, 6 months
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).	6 months
Change from baseline in pain bothersomeness in previous week	Bothersomeness in previous week as measured on a 100 mm visual analog scale (0-100).	3 months, 6 months
Change from baseline in pain medication use in the previous week	Specific self-reported pain medication use in previous week.	3 months, 6 months
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.	3 months, 6 months
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.	3 months, 6 months
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.	3 months, 6 months
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.	3 months, 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events as a measure of safety and treatment adherence	Identify and assess self reported and unanticipated adverse events over the course of the study as a measure of safety and treatment adherence.	3 months, 6 months
Treatment adherence (class/session attendance)	Assess treatment adherence according to attendance during 12 week intervention period.	3 months, 6 months
App via mobile phones	Use of an mobile app to assess back pain intensity, pain medication, practice time	3 times daily within baseline and 6 months

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2023
• Primary Completion (Actual): September 26, 2023
• Study Completion (Actual): September 26, 2023

Study Registration Dates

• First Submitted: April 20, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: NHKManual

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No