Manual Therapy on the Improvement of Functional Disability in Patients With Chronic Non Specific Low Back Pain

University of Applied Sciences of Western Switzerland

Status: Completed

Conditions: Back Pain Lower Back Chronic

Treatments: Procedure: Detuned ultrasound and active exercises; Procedure: Manual therapy and active exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT01496144

FNS13DPD3-109903 (Other Grant/Funding Number)

Details and patient eligibility

About

Background: Models have tried to explain the driving mechanisms behind chronic non specific low back pain (CNSLBP) in order to propose better appropriate conservative treatment. Altered responses at spinal and/or supraspinal level may affect the perception of pain and degree of disability of CNSLBP patients. Recent clinical recommendations still propose active exercises (AE) for CNSLBP. However, acceptance of exercises by patients may be limited by pain-related manifestations. Current evidences suggest manual therapy (MT) induces a short-term analgesic effect through neurophysiological mechanisms at peripheral, spinal and cortical levels. The aim of this study was first, to assess whether MT has an instant analgesic effect, and second, to compare the long-lasting effect on functional disability of MT followed by AE to sham therapy (ST) followed by AE. Methods: Forty-two CNSLBP patients without co-morbidities, randomly distributed into 2 treatment groups, received either spinal manipulation/mobilization (first intervention) plus AE (MT group; n = 22), or detuned ultrasound (first intervention) plus AE (ST group; n = 20). Eight therapeutic sessions were delivered over 4 to 8 weeks. Instant analgesic effect was obtained by measuring pain intensity (Visual Analogue Scale) before and immediately after the first intervention of each therapeutic session. Pain intensity, disability (Oswestry Disability Index) and fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire) were determined before treatment, after the 8th therapeutic session, and at 3- and 6-month follow-ups.

Enrollment: 42 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• suffering from non specific low back pain with or without symptoms in the lower extremity for a period between 12 and 26 weeks
• can maintain the usual medication

Exclusion criteria

• spinal fracture or surgery within the previous 6 months
• pregnancy
• neoplasia
• spinal infection
• spinal inflammatory arthritis
• low back pain of visceral origin
• severe sensitive and/or motor radicular deficit from nerve root origin of less than 6 months
• score of 3/5 or more on the Waddell Score
• on sick leaves from work for 6 months or more
• psychiatric disorders
• opioid medication
• patient unable to collaborate (linguistic barrier; cognitive impairments)
• radiologic abnormalities other than degenerative disease
• clinical neurogenic claudication.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups, including a placebo group

Manual therapy and active exercises

Experimental group

Description:

Spinal manipulation /mobilisation

Treatment:

Procedure: Manual therapy and active exercises

Detuned ultrasound and active exercises

Placebo Comparator group

Treatment:

Procedure: Detuned ultrasound and active exercises