Study of Effectiveness of Pold in Chronic Nonspecific Low Back Pain

NCT01591824 | Completed

• 1 other identifier: Pold-LBP
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Through this research is to conduct a pilot clinical trial in the treatment of chronic nonspecific low back pain (degenerative and mechanical), by comparing two groups, one that will apply a technique of physiotherapy by passive movement of the column with oscillations in axial rotation at a frequency of 1.5 to 2 cps (resonance) of low amplitude (called "Pold Concept"), another group that applies the standard protocol of treatment for this condition, as used in the hospital where performed the study. It will compare the levels of efficiency and effectiveness of each treatment and the comparison between them. This will measure the perception of pain intensity and disability.

Conditions

Mechanical Low Back Pain

Outcome Measures

Primary Outcomes (1)

• VAS pain measurement

  Visual analog scale of pain measurement, with values between zero and ten where zero is total absence of pain and 10 the maximum pain imaginable by the patient, distributed in a horizontal line, without intermediate numerical or graphic references.

  Participants will be followed for the duration of treatment application, an expected average of 3 weeks.

Secondary Outcomes (2)

• SF-12 Health Survey

  Participants will be followed for the duration of treatment application, an expected average of 3 weeks.

• Oswestry Disability Index

  Participants will be followed for the duration of treatment application, an expected average of 3 weeks.

Study Arms (2)

POLD TREATMENT

EXPERIMENTAL

Patients who applies the treatment of resonant oscillation according to the Pold Concept

Other: Resonant oscillation

CONVENCIONAL: column exercise group

ACTIVE COMPARATOR

Patients who applied the conventional treatment of hospital

Other: column exercise group

Interventions

Resonant oscillation OTHER

Resonant sustained oscillations are applied in the following areas * general column. * lumbar muscles, and paraspinal muscles, * sacral decompression oscillatory * Opening by lateral vertebral lumbar rhythmic swing. * Balancing and pelvic decompression * Swing-lumbar vertebral rotation.

Also known as: oscillatory movement

POLD TREATMENT

column exercise group OTHER

* paraspinal muscle stretching exercises * postural correction * mobilization exercises thoracic and lumbar * Motor control exercises

Also known as: motor control

CONVENCIONAL: column exercise group

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having a diagnosis instrumental prior to treatment to rule out pathologies pollutants, neurological or structural malformations.
• No previous trauma.
• Age between 25 and 65.
• With similar clinical characteristics to have a homogenous group:
• Low back pain (\> 3 months) and that at the time the study began have a minimum of 3/10 on VAS scale, following the criteria established in similar studies
• without component of neurological lower limbs irradiation

You may not qualify if:

• Existence of other recent traumatic structural pathologies in the lumbar region or of another type that could disturb the study.
• Existence of irradiation metameric to lower limbs
• Current tumors in the lumbar region
• Ongoing infectious disease in the lumbar area.
• Inflammatory rheumatism in the lumbar region.
• Lumbar surgery complications.
• Ongoing pregnancy.
• They have been treated with infiltrations in the last month.
• Who are following any other treatment, whether manual or physical agents or alternative or complementary therapies.

Sponsors & Collaborators

• Omphis Foundation: lead

Study Sites (1)

Esperanza Hospital

Barcelona, 08024, Spain

Location

Related Links

• Click here for more information about Omphis Foundation activities, Clinic, teaching and research

MeSH Terms

Conditions

Low Back Pain

Interventions

Functional Laterality

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dominance, Cerebral; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• José M. Muniesa, physiatrist

  Esperanza Hospital (Barcelona)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Degree in physiotherapy kinesiology and physiatry

Study Record Dates

• First Submitted: May 1, 2012
• First Posted: May 4, 2012
• Study Start: May 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: September 1, 2015
• Last Updated: April 9, 2019

Record last verified: 2019-04

Locations

ES (1)