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Sponsor did not want to continue the study.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual Therapy/Exercises | Behavioral | Three individual therapy sessions and nine group sessions manual therapy/exercises of 60 min. duration under the guidance of a trained therapist. |
| 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 |
| 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 |
| 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) |
Inclusion Criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charite University | Berlin | 14109 | Germany |
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| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| Physiotherapy/Back School | Behavioral | Three individual therapy sessions and nine group sessions physiotherapy/back school of 60 min. duration under the guidance of a trained therapist. |
|
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 |
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 |
| D009043 |
| Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |