Efficacy of Passive Joint Mobilization vs Mobilization With Movement on Pain Processing in Patients With Chronic Low Back Pain

Universidad Rey Juan Carlos

Status: Unknown

Conditions: Chronic Low-back Pain

Treatments: Other: Mobilization with movement; Other: Passive joint mobilization

Study type: Interventional

Funder types: Other

Identifiers

NCT04940715

1003202108421

Details and patient eligibility

About

Patients with chronic low back pain may have altered pain processing, making them vulnerable to pain or disability. It can be measured with test like pressure pain threshold, temporal summation or conditioned pain modulation. Manual therapy has shown improve this pain processing variables in other conditions (like knee osteoarthritis or lateral elbow pain), although the quality of the evidence is low in terms of temporal summation and controversial in terms of conditioned pain modulation. There are not studies that had investigated the impact of manual therapy techniques on pain processing in patients with chronic low back pain.

Full description

Study Aims:

Aim #1: The main objective of this study is to determine the efficacy of two manual therapy approaches (passive joint mobilization and mobilization with movement) on pain (measured with Visual Analogue Scale) and pain processing (measured with pressure pain threshold, temporal summation and conditioned pain modulation) in patients with chronic low back pain and see its results on short, medium and long term.

Aim #2: The secondary objective is to compare the effect of both manual therapy techniques with an inactive control group in terms of pain and pain processing.

Aim #3: Determine the efficacy of manual therapy on intervention groups on psychological outcomes as catastrophizing (Pain Catastrophizing Scale), kinesiophobia (Tampa Scale of Kinesiophobia) and depression (Beck Depressive Inventory) and compare them with control group.

Methodology Research Design: Randomized, longitudinal, experimental, prospective, parallel and double-blind study with patients with chronic low back pain.

Participants: Adults between 18-65 years old residing Comunidad de Madrid, all of whom were recruited personally for the study. All patients will read the information sheet explaining what the study will consist, as well as the informed consent form, which they will sign voluntarily beforehand.

Sample Size: The sample size will be calculated by means of the "Gpower 3.0.18" computer program.

Randomization: Randomization will be done through the GraphPad software (GraphPad Software, Inc CA 92037 USA). Patients who meet the inclusion criteria and have none of the exclusion criteria will be entered into the study and the sample will be randomized to obtain three groups in opaque and sealed envelopes: A (passive joint mobilization), B (mobilization with movement) and C (control group).

Masking: The double-blind criteria are met, in which the subjects participating in the study will not know the group to which they were assigned, as well as the physiotherapist in charge of collecting the outcomes data.

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non-specific chronic low back pain patients, without lower limb pain
• Pain lasting 6 months or more
• Pain measure of 2 or more on a 0 to 10 scale
• Age between 18-65 years old
• Haven't received physical therapy during last month

Exclusion criteria

• Radiculopathy
• Neurological signs, symptoms or deficit
• Rheumatic/autoimmune/systemic disease
• History of fracture, trauma or previous spinal surgery
• Pregnancy
• Disc herniation
• Neuropathic pain
• Active cancer
• Spondylolysis/Spondylolisthesis
• Cognitive impairment
• Long-term opioid intake

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 3 patient groups

Passive joint mobilization

Experimental group

Description:

Patients lay down on a prone position, with their hands around the body and neck placed comfortable. The therapist performed a postero-anterior joint mobilization using Maitland's technique, applying pressure to spinous process of targeted vertebra (the one who reproduces patient's symptoms).

Treatment:

Other: Passive joint mobilization

Mobilization with movement

Experimental group

Description:

Patients perform their painful movement (flexion, extension...). If pain wasn't reproduced, a combination of movements will be performed (flexion + rotation...). The most painful vertebral level was assessed too with passive accessory vertebral movements. Afterwards, with the patient on a seated position on a stretcher with feet supported and a belt around the waist, the therapist performed a sustained glide on the targeted vertebra (spinous process) with the force and direction that relieved pain to the lowest level.

Treatment:

Other: Mobilization with movement

Control group

No Intervention group

Description:

Patients were measured at baseline and then were placed on "wait list" until the end of the study. At this time, they were measured again.