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

Chronic Low-back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05843149
• Other study ID #: NHKManual
• Status: Terminated
• Phase: N/A
• Start date: May 2, 2023
• Est. completion date: September 26, 2023

Study information

• Verified date: October 2023
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: September 26, 2023
• Est. primary completion date: September 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Charite University	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Treatment adherence (class/session attendance)	Assess treatment adherence according to attendance during 12 week intervention period.	3 months, 6 months
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change from baseline in pain medication use in the previous week	Specific self-reported pain medication use in previous week.	3 months, 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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