Neck Pain Clinical Trial
Official title:
Subacute and Chronic, Non-specific Back and Neck Pain: Cognitive-behavioral Rehabilitation Compared With Traditional Primary Care Concerning Sick-listing and Health-care Visits. A Randomized Controlled Trial, 18-month Follow-up
Verified date | June 2007 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Regional Ethical Review Board |
Study type | Interventional |
BACKGROUND
Non-specific back and neck pain (BNP) dominates sick-listing. A program of
cognitive-behavioral rehabilitation for subacute and chronic BNP was compared, with 18-month
follow-up, with traditional primary care concerning sick-listing and health-care visits.
METHODS
After stratification to age (44 (years) and younger/45 and older) and subacute/chronic BNP
(= full-time sick-listed 43-84/85-730 days respectively), 125 primary-care patients were
randomized to a rehabilitation center or continued health-center care. Outcome measures were
Return-to-work (=the proportion who regained work ability for at least 30 consecutive days),
the proportion with Work ability at different time points, Total sick-listing (expressed in
whole days) and the total number of Visits (to physicians, physiotherapists etc.) 1-18
months and corresponding six-month periods. For the analyses were used t-test, z-test,
generalized estimating equations and a mixed, linear model.
Status | Completed |
Enrollment | 125 |
Est. completion date | July 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 59 Years |
Eligibility |
Inclusion Criteria: 1. Working age up to and including 59 years. 2. Sick-listed full-time for BNP for at least 42 days and at most 730 days. 3. Able to manage tolerably well to fill in forms. Exclusion Criteria: 1. Temporary disability pension or disability pension being paid or in preparation. 2. A primary need of action by a hospital specialist. 3. Pregnancy and diseases which would probably make rehabilitation impracticable (for example, advanced pulmonary disease). 4. Whiplash-associated disorders as a primary obstacle to working. 5. Previous rehabilitation at the rehabilitation centre. 6. Other multidisciplinary rehabilitation going on or planned. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Centre for Family Medicine | Stockholm | Huddinge |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet |
Sweden,
Alexanderson K, Norlund A. Swedish Council on Technology Assessment in Health Care (SBU). Chapter 1. Aim, background, key concepts, regulations, and current statistics. Scand J Public Health Suppl. 2004;63:12-30. Review. — View Citation
Brown H, Prescott R: Applied mixed models in medicine. Edinburgh: John Wiley & Sons LTD; 199-259, 2001.
Lindell O, Eriksson L, Strender LE. The reliability of a 10-test package for patients with prolonged back and neck pain: could an examiner without formal medical education be used without loss of quality? A methodological study. BMC Musculoskelet Disord. — View Citation
Lindström I, Ohlund C, Eek C, Wallin L, Peterson LE, Fordyce WE, Nachemson AL. The effect of graded activity on patients with subacute low back pain: a randomized prospective clinical study with an operant-conditioning behavioral approach. Phys Ther. 1992 Apr;72(4):279-90; discussion 291-3. — View Citation
Linton SJ: Utility of cognitive-behavioral psychological treatments. In Neck and back pain. The scientific evidence of causes, diagnosis, and treatment. Edited by Nachemson A, Jonson E. Philadelphia: Lippincott, Williams & Williams; 2000:361-381.
Söderström M, Englund L: Treatment of neck and low back pain in primary care. In Neck and back pain. The scientific evidence of causes, diagnosis, and treatment. Edited by Nachemson A, Jonson E. Philadelphia: Lippincott, Williams & Williams; 2000:383-398.
Waddell G. Low back pain: a twentieth century health care enigma. Spine (Phila Pa 1976). 1996 Dec 15;21(24):2820-5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Return-to-work=the proportion of patients who during 1-18 months regained a degree of work ability>0 for at least 30 days in succession. | 18 months. | ||
Secondary | Work ability (=the proportion with work ability>0). Total sick-listing=the sum of sick-listing of any degree, expressed in whole days. Visits=the total number of consultations to different health-care staff, for example, physicians or physiotherapists. | Work ability: 18 months. Total sick-listing: 36 months (18 months preceding and after inclusion). Visits: 18 months. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05293847 -
Postural Based Telerehabilitation in Mechanic Neck Pain
|
N/A | |
Completed |
NCT04060004 -
The Effects of Dry Needling on the Superficial Neck Musculature
|
N/A | |
Recruiting |
NCT06204627 -
TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain
|
N/A | |
Active, not recruiting |
NCT05870371 -
The Effect of the Feldenkrais Method on Pain and Function in Patients With Chronic Neck Pain
|
N/A | |
Completed |
NCT06049316 -
Scapular Stabilization vs Functional Exercises on Chronic Neck Pain
|
N/A | |
Recruiting |
NCT05944354 -
Wearable Spine Health System for Military Readiness
|
||
Completed |
NCT02904668 -
Self-management Program in Chronic Neck Pain
|
N/A | |
Completed |
NCT02731014 -
Dry Needling for Patients With Neck Pain
|
N/A | |
Completed |
NCT03147508 -
Investigating Clinical Indicators of Spine Related Dysfunction Patterns. A Clinical Study on Neck Pain Patients.
|
||
Completed |
NCT02882061 -
Examination of Cervical Thoracic Differentiation Testing in Individuals With Neck Pain
|
N/A | |
Completed |
NCT02638987 -
EMG Activity Before, During and After Dry Needling
|
N/A | |
Active, not recruiting |
NCT02843269 -
Multiple-component Workplace FRamed Intervention to Decrease Occupational Muscle Pain - FRIDOM
|
N/A | |
Enrolling by invitation |
NCT02485795 -
Observational Study of the Impact of Genetic Testing on Healthcare Decisions and Care in Interventional Pain Management
|
N/A | |
Completed |
NCT02245425 -
Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain
|
N/A | |
Completed |
NCT02235207 -
Effectiveness of Fustra—Exercise Program in Neck and Low Back Pain
|
N/A | |
Completed |
NCT02225873 -
The Effectiveness of Exercises Protocol in Management of Neck Pain
|
N/A | |
Completed |
NCT02190890 -
Dry Needling Dosage in the Treatment of Myofascial Neck Pain
|
N/A | |
Completed |
NCT02051478 -
Thoracic Manipulation and Mobilization for Neck Pain
|
N/A | |
Completed |
NCT01938209 -
A Comparison of Seated Thoracic Manipulation and Targeted Supine Thoracic Manipulation on Cervical Flexion Motion and Pain
|
N/A | |
Completed |
NCT01233180 -
Effects of Gua Sha and Thermotherapy on Chronic Neck Pain
|
N/A |