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

Manual Therapy Followed by Specific Active Exercises Versus a Placebo Followed by Specific Active Exercises on the Improvement of Functional Disability in Patients With Chronic Non Specific Low Back Pain: a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01496144
Enrollment
42
Registered
2011-12-21
Start date
2005-12-31
Completion date
2011-01-31
Last updated
2011-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back Pain Lower Back Chronic

Keywords

Chronic non specific low back pain, Manual therapy, Active exercises, Pain, Disability

Brief summary

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.

Interventions

PROCEDUREManual therapy and active exercises

Spinal manipulation/mobilisation (5-10 minutes), consisting of passive accessory intervertebral movements, muscle-energy techniques and high velocity, low amplitude dynamic thrust. Active exercises (20 minutes), consisting of mobility, stretching, strengthening and motor control exercises

PROCEDUREDetuned ultrasound and active exercises

Electrotherapy device inactivated and ineffective. Active exercises, consisting of mobility, stretching, strengthening and motor control exercises

Sponsors

Centre Hospitalier Universitaire Vaudois
CollaboratorOTHER
University of Applied Sciences of Western Switzerland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Visual Analogue Scale - VAS-painDuring treatment, over a period of 4 to 8 weeksself-report of clinical pain intensity, consisting of a 10 cm horizontal line scale on which is added the statements no pain on the left and maximum intensity of pain on the right

Secondary

MeasureTime frameDescription
Fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire - FABQ)Before randomization and untill 6 months after the end of treatmentmeasures level of fear and avoidance beliefs about work and physical activity in patients with low back pain

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026