General versus specific spinal manipulation for back pai

Not Applicable

Completed

• Conditions: ower back pain; Injury, Occupational Diseases, Poisoning; Lower back pain

• Registration Number: ISRCTN11994230
• Lead Sponsor: niversity of Manchester

Brief Summary

2019 results in: http://dx.doi.org/10.1136/bmjsem-2019-000514 (added 22/10/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2007-06-11
• Study Start: 2017-04-12
• Last Update Posted: 11 November 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

1. Adults aged 18 to 60 with low back pain
2. Roland Morris Pain and Disability Questionnaire (RM) score of 4 or more at the initial examination
3. Symptoms for at least 3 weeks

Exclusion Criteria

1. Frank spinal deformity
2. Lumbosacral anomalies
3. Neoplastic disease of skeletal or soft tissue of the spine
4. Bone disease e.g. Paget’s disease, osteoporosis, osteomyelitis
5. Inflammatory arthritis, rheumatoid arthritis, ankylosing spondylitis
6. Gout
7. Cord signs: signs of a upper motor neuron lesion at the spinal cord level
8. Positive Lhermitte’s sign: This is where on flexion of the neck tingling or shock like sensations run down the arms to the fingers or down the legs and is a sign of a lesion in the posterior columns of the cervical cord (Draper, 1985).
9. Cervical and thoracic joint conditions producing neurological symptoms in one or both lower limbs
10. Evidence of involvement of one or more spinal nerve root
11. Cauda equina syndrome- triad of low back and or leg pain, numbness in the sacral region and loss of bladder or bowel control (Draper, 1985).
12. Advanced diabetes when tissue vitality might be low
13. Vascular abnormalities, visceral arterial disease
14. Congenital generalised hypermobility Ehlers-Danlos syndrome
15. Advanced degenerative changes
16. Severe root pain
17. Undiagnosed pain
18. Painful joint conditions, psychologically reinforced where manipulation runs the risk of producing an obsessional neurosis of vertebral displacement.
19. Warfarin sodium anticoagulant medication.
20. Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain is measured using the Visual Analogue Scale for pain experienced at baseline and after session one, two and three.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Self-reported disability is measured using Roland Morris Disability Questionnaire at baseline and after session one, two and three<br> 2. Pressure pain threshold is measured using a manual algometry pressure on the spinal muscles at baseline and after session one, two and three<br> 3. Muscular reflexogenic responses (peak EMG amplitude) are measured using surface electromyography at session one, two and three<br>