Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
to investigate the effects of placebo in patients affected by low-back pain.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OMT | Active Comparator | Participants will receive manual treatments. The treatment will include soft-tissue, joint mobilization techniques of the lumbar and sacral region. The treatment will also include the approach of the abdomen and lower limb with the same type of techniques. Four treatments will be provided at 1, 2, 4 and 8 weeks. |
|
| Open-label placebo | Experimental | This group will receive an open-label placebo. The manual treatment will be performed in the same areas of the active comparator but using a very light pressure. Additionally, before the start of the treatment, Four treatments will be provided at 1, 2, 4 and 8 weeks. |
|
| Waiting list | No Intervention | Participants will receive no treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open-label placebo | Other | Light pressure manual therapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Numeric Rating Scale | a verbal determination of a pain level on a scale from 0 to 10, in which 0 represents no pain and 10 represents excruciating pain. | Change from baseline of numeric rating scale at week 2, 4 and 8. |
| Adverse effects | Number and types of adverse effects occurred after intervention | through study completion (8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in measures of Von Frey filaments | Changes in pressure measures | from baseline at week 2,4 and 8. |
| Changes in algometer measurements | Changes in pressure with algometer |
Not provided
Inclusion Criteria:
Adult patients (+18 years) who complain of chronic non-specific low back pain for at least 3 months with or without pain exacerbations at the time of recruitment, will be included.
-Patients will need to have a diagnosis of low back pain made by a physician
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CTFO | Saronno | Varese | 21047 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D026301 | Manipulation, Osteopathic |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Osteopathic manipulative treatment |
| Other |
Manual therapy |
|
| from baseline at week 2, 4 and 8 |
| Use of analgesics | Usage (Yes/no), number and type of analgesics used | The week before the scheduled visit. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012046 | Rehabilitation |