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The purpose of this study is to evaluate prospectively the effectiveness of acupuncture as adjunctive therapy in the treatment of spinal pain is the three backbone areas: cervical, thoracic and lumbar pain, under conditions of usual clinical practice as the medical acupuncturist performed acupuncture, with and without supplementary pharmacological treatment during the first 4 weeks of follow up.
Epidemiological, observational, prospective, with two cohorts, naturalistic and non-interventionist study.
The disease to be studied is Back pain (cervical, thoracic or lumbar) caused by musculoskeletal pathologies and previously treated with conventional medical treatment with or without treatment currently.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With usual concomitant treatment | Two observational cohorts of patients will be evaluated: with and without concomitant analgesic/ antiinflammatory drugs. The objective is evaluate that both therapies (drugs and acupuncture) could be used as adjunctive therapy in order to maximize the analgesia that could be reached | ||
| Without usual concomitant treatment | This group include patients that are not been treated with analgesic drugs at the beginning of the study. As an observational and naturalistic study any indicated treatment is allowed in any time |
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| Measure | Description | Time Frame |
|---|---|---|
| VAS: Visual Analogic Scale of pain | Pain assesment will be evaluated using a Visual Analogic Scale of pain (VAS). This variable will be evaluated in all 10 visits and it will be showed its evolution (decrease) along the study | 10 weekly visits |
| Measure | Description | Time Frame |
|---|---|---|
| Sheehan Disability Questionnaire | Sheehan Disability Questionnaire, this validated questionnaire will be administrated in Visit 1 (Basal) and Visit 10 (Final) and it will be compared if there has been statistical differences between both evaluations | First Visit (week 1) and Final Visit (week 10) |
| Evaluation of the Scale Hospital Anxiety Depression (HAD) |
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Inclusion Criteria:
Exclusion Criteria:
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The study population is patients who go to the Acupuncture Office diagnosed of cervical, thoracic or lumbar pain caused by musculoskeletal diseases, pretreated with pharmacological treatment, they start treatment with acupuncture as adjunctive therapy for symptoms of their disease.
Initially it was estimated that the optimal number of patients included to achieve the objectives of the study is 102 patients
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| Name | Affiliation | Role |
|---|---|---|
| Valentin Martin, MD, PhD | Grupo G6 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| I.H. Hospital San Jose | Madrid | Madrid | 20010 | Spain |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| D009140 | Musculoskeletal Diseases |
| D019547 | Neck Pain |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Scale Hospital Anxiety Depression (HAD), this scale will be evaluated using a validated questionnaire administrated in Visit 1 (basal) and Visit 10 (Final) and it will be compared if there has been statistical differences between both evaluations |
| First Visit (week 1) and Final Visit (week 10) |
| Health Questionnaire EuroQol-5D | Health Questionnaire EuroQol-5D, this validated questionnaire will be administrated in Visit 1 (Basal) and Visit 10 (Final) and it will be compared if there has been statistical differences between both evaluations | First Visit (week 1) and Final Visit (week 10) |
| Assessment of sleep with the integrated scale MOS (Medical Outcomes Study) | Assessment of sleep with the integrated scale MOS (Medical Outcomes Study), this scale will be evaluated using a validated questionnaire administrated in Visit 1 (basal) and Visit 10 (Final) and it will be compared if there has been statistical differences between both evaluations | First Visit (week 1) and Final Visit (week 10) |
| McGill Pain Questionnaire | A secondary evaluation of pain suffered by the patients will be evaluated using the validated McGill Pain Questionnaire. This questionnaire will be adminstrated in all 10 visits and it will be showed its evolution (decrease) along the study | 10 weekly visits |