Chronic Low-back PainNCT05843149
Manual Therapy/Exercises vs. Physiotherapy/Back School vs. Waiting List in Patients With Chronic Low Back Pain
A study testing Manual Therapy/Exercises and Physiotherapy/Back School in people with Chronic Low-back Pain, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Manual Therapy/Exercises and Physiotherapy/Back School
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteGermany
- Study dates
- 2 May 2023to 26 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- Ankylosing spondylitis
- Severe comorbidities
- Pregnancy/lactation
- Current participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Low-back Pain
- Being tested
- Manual Therapy/Exercises, Physiotherapy/Back School
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Therapy/ExercisesBehavioural
Three individual therapy sessions and nine group sessions manual therapy/exercises of 60 min. duration under the guidance of a trained therapist.
Physiotherapy/Back SchoolBehavioural
Three individual therapy sessions and nine group sessions physiotherapy/back school of 60 min. duration under the guidance of a trained therapist.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Secondary outcomes (8)
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.
Measured: 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).
Measured: 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).
Measured: 3 months, 6 months
Change from baseline in pain medication use in the previous week
Specific self-reported pain medication use in previous week.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start2 May 2023
- Primary completion26 Sep 2023
- Study completion26 Sep 2023
Why it stopped: Sponsor did not want to continue the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843149
- Sponsor's protocol ID
- NHKManual
- Status last verified
- Oct 2023
- First submitted
- 20 Apr 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Therapy/Exercises vs. Physiotherapy/Back School vs. Waiting List in Patients With Chronic Low Back Pain - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05843149
- Acronym / sponsor ID
- NHKManual
- Conditions
- Chronic Low-back Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor did not want to continue the study.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 26 Sep 2023 (actual)
- Study completion
- 26 Sep 2023 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy/Exercises | Experimental | Behavioral: Manual Therapy/ExercisesThree individual therapy sessions and nine group sessions manual therapy/exercises of 60 min. duration under the guidance of a trained therapist. |
| Physiotherapy/Back School | Experimental | Behavioral: Physiotherapy/Back SchoolThree individual therapy sessions and nine group sessions physiotherapy/back school of 60 min. duration under the guidance of a trained therapist. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Therapy/ExercisesThree individual therapy sessions and nine group sessions manual therapy/exercises of 60 min. duration under the guidance of a trained therapist. | Behavioural | Manual Therapy/Exercises |
| Physiotherapy/Back SchoolThree individual therapy sessions and nine group sessions physiotherapy/back school of 60 min. duration under the guidance of a trained therapist. | Behavioural | Physiotherapy/Back School |
Primary outcome
Change from baseline in average pain intensity in previous week
Time frame: 3 months
Intensity of pain in previous week as measured on a 100 mm visual analog scale (0-100).
8 secondary outcomes
Change from baseline for back pain specific disability
Time frame: 3 months, 6 months
Change from baseline in average pain intensity in previous week
Time frame: 6 months
Change from baseline in pain bothersomeness in previous week
Time frame: 3 months, 6 months
Change from baseline in pain medication use in the previous week
Time frame: 3 months, 6 months
Change from baseline for health related quality of life
Time frame: 3 months, 6 months
Change from baseline for pain self-efficacy
Time frame: 3 months, 6 months
Change from baseline for work productivity
Time frame: 3 months, 6 months
Change from baseline for anxiety and depression
Time frame: 3 months, 6 months
Results and safety
The study was stopped early (reason given: Sponsor did not want to continue the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy/Exercises and Physiotherapy/Back School in people with Chronic Low-back Pain, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor did not want to continue the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in average pain intensity in previous week (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.