NCT05843149

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

May 2, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2023

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

5 months

First QC Date

April 20, 2023

Last Update Submit

October 24, 2023

Conditions

Chronic Low-back Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Change from baseline for back pain specific disability

    3 months, 6 months

  • Change from baseline in average pain intensity in previous week

    6 months

  • Change from baseline in pain bothersomeness in previous week

    3 months, 6 months

  • Change from baseline in pain medication use in the previous week

    3 months, 6 months

  • Change from baseline for health related quality of life

    3 months, 6 months

  • +3 more secondary outcomes

Other Outcomes (3)

  • Number of participants with adverse events as a measure of safety and treatment adherence

    3 months, 6 months

  • Treatment adherence (class/session attendance)

    3 months, 6 months

  • App via mobile phones

    3 times daily within baseline and 6 months

Study Arms (3)

Manual Therapy/Exercises

EXPERIMENTAL

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

Physiotherapy/Back School

EXPERIMENTAL

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

Waiting List

NO INTERVENTION

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.

Interventions

Manual Therapy/ExercisesBEHAVIORAL

Three individual therapy sessions and nine group sessions manual therapy/exercises of 60 min. duration under the guidance of a trained therapist.

Manual Therapy/Exercises
Physiotherapy/Back SchoolBEHAVIORAL

Three individual therapy sessions and nine group sessions physiotherapy/back school of 60 min. duration under the guidance of a trained therapist.

Physiotherapy/Back School

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite University

Berlin, 14109, Germany

Location

MeSH Terms

Interventions

Musculoskeletal ManipulationsExercise

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 20, 2023

First Posted

May 6, 2023

Study Start

May 2, 2023

Primary Completion

September 26, 2023

Study Completion

September 26, 2023

Last Updated

October 25, 2023

Record last verified: 2023-10

Locations

DE(1)