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

NCT04940715 | Unknown

• 1 other identifier: 1003202108421
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Low-back Pain

Keywords

Chronic low back pain; Pain processing; Manual Therapy

Outcome Measures

Primary Outcomes (4)

• Pain

  Visual Analogue Scale (VAS) was used to measure pain. It consists of a 100mm length line and has written "no pain" and "worst pain imaginable" on its ends and measures pain intensity. The confidence and reliability of this scale has been approved and validated in different studies.

  Change from baseline, after the first intervention, after the last intervention and at both follow-up (1 month and 3 months) periods.

• Pressure pain threshold

  A digital algometer was used to measure mechanical hyperalgesia. The model was de X® brand, consisting of a 1cm2 cylindrical rubber attached to a pressure gauge, calibrated in kilograms (kg). The scale expressed in kg/cm2 was used. Before the measurement, patients were trained in forearm muscles through a trial session. They were instructed to say STOP when the pressure sensation was painful. For the measurement, patients lay down on prone position on the stretcher and the algometer was placed perpendicular to skin on the measured points, who were marked prior to measurement (2cm lateral to L5 spinous process, C2 spinous process, ipsilateral anterior tibialis and contralateral epicondyle). A rest period of 30 seconds was established between the measurements. For each point, three measurements were done and their mean was calculated and recorded for analysis. The minimum detectable change (CMD) for considering the results as clinically relevant was established at 15% minimum.

  Time Frame: Change from baseline, after the first intervention, after the last intervention and at both follow-up (1 month and 3 months) periods.

• Temporal summation

  Temporal summation was measured with Von Frey monofilaments. Patients lay down on prone position and measurements were taken 1cm lateral to spinous process of L4. First, a single stimulus was applied and the patient assessed the pain intensity on a 0-10 numeric rating scale. After that, 10 rhythmic stimuli were applied on the same spot (1 stimuli per second) and the patient assessed again the pain intensity. The temporal summation effect was calculated as the difference between the mean rating of the three repetitions of one stimulus and the mean rating of the three repetitions of 10 stimulus.

  Change from baseline, after the first intervention, after the last intervention and at both follow-up (1 month and 3 months) periods.

• Conditioned pain modulation

  Conditioned pain modulation was measured with tourniquet test. A sphygmomanometer was used to induce ischemic muscle pain as conditioning stimulus (model X®). It was applied around the contralateral upper arm, 3cm proximal to cubital fossa. Now, pressure pain threshold 2cm lateral to L5 spinous process was measured. Afterwards, the cuff was inflated to 260mmHg and maintained until the patient perceived a pain intensity of 6 on a 0-10 numeric rating pain scale. Then, the pressure pain threshold was measured again at the same spot during the conditioning stimulus and then the cuff pressure was released. The conditioned pain modulation value is the result of the subtraction of the value of the PPT during the conditioning stimulus minus the PPT without it.

  Change from baseline, after the first intervention, after the last intervention and at both follow-up (1 month and 3 months) periods.

Secondary Outcomes (5)

• Pain Catastrophizing

  Changes from baseline, after the last intervention and at both follow-up periods (1 month and 3 months).

• Kinesiophobia

  Changes from baseline, after the last intervention and at both follow-up periods (1 month and 3 months).

• Depression

  Changes from baseline, after the last intervention and at both follow-up periods (1 month and 3 months).

• Central sensitization

  Changes from baseline, after the last intervention and at both follow-up periods (1 month and 3 months).

• Disability

  Changes from baseline, after the last intervention and at both follow-up periods (1 month and 3 months).

Study Arms (3)

Passive joint mobilization

EXPERIMENTAL

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).

Other: Passive joint mobilization

Mobilization with movement

EXPERIMENTAL

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.

Other: Mobilization with movement

Control group

NO INTERVENTION

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.

Interventions

Passive joint mobilization OTHER

Dosage: 5 sets of 2 minutes with 30 seconds of rest were applied, with a strong force (\>50% of maximum therapist strength), according to patient's irritability and severity.

Passive joint mobilization

Mobilization with movement OTHER

Dosage: 3 sets of 10 repetitions were performed, with 1-2 minutes of rest between sets.

Mobilization with movement

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Location

Related Publications (7)

• den Bandt HL, Paulis WD, Beckwee D, Ickmans K, Nijs J, Voogt L. Pain Mechanisms in Low Back Pain: A Systematic Review With Meta-analysis of Mechanical Quantitative Sensory Testing Outcomes in People With Nonspecific Low Back Pain. J Orthop Sports Phys Ther. 2019 Oct;49(10):698-715. doi: 10.2519/jospt.2019.8876. Epub 2019 Aug 23.

  PMID: 31443625 BACKGROUND

• Neelapala YVR, Bhagat M, Frey-Law L. Conditioned Pain Modulation in Chronic Low Back Pain: A Systematic Review of Literature. Clin J Pain. 2020 Feb;36(2):135-141. doi: 10.1097/AJP.0000000000000778.

  PMID: 31764164 BACKGROUND

• McPhee ME, Vaegter HB, Graven-Nielsen T. Alterations in pronociceptive and antinociceptive mechanisms in patients with low back pain: a systematic review with meta-analysis. Pain. 2020 Mar;161(3):464-475. doi: 10.1097/j.pain.0000000000001737.

  PMID: 32049888 BACKGROUND

• Alkhawajah HA, Alshami AM. The effect of mobilization with movement on pain and function in patients with knee osteoarthritis: a randomized double-blind controlled trial. BMC Musculoskelet Disord. 2019 Oct 18;20(1):452. doi: 10.1186/s12891-019-2841-4.

  PMID: 31627723 BACKGROUND

• Lascurain-Aguirrebena I, Newham D, Critchley DJ. Mechanism of Action of Spinal Mobilizations: A Systematic Review. Spine (Phila Pa 1976). 2016 Jan;41(2):159-72. doi: 10.1097/BRS.0000000000001151.

  PMID: 26751060 BACKGROUND

• Aspinall SL, Jacques A, Leboeuf-Yde C, Etherington SJ, Walker BF. No difference in pressure pain threshold and temporal summation after lumbar spinal manipulation compared to sham: A randomised controlled trial in adults with low back pain. Musculoskelet Sci Pract. 2019 Oct;43:18-25. doi: 10.1016/j.msksp.2019.05.011. Epub 2019 May 31.

  PMID: 31176287 BACKGROUND

• Arribas-Romano A, Fernandez-Carnero J, Molina-Rueda F, Angulo-Diaz-Parreno S, Navarro-Santana MJ. Efficacy of Physical Therapy on Nociceptive Pain Processing Alterations in Patients with Chronic Musculoskeletal Pain: A Systematic Review and Meta-analysis. Pain Med. 2020 Oct 1;21(10):2502-2517. doi: 10.1093/pm/pnz366.

  PMID: 32100027 BACKGROUND

MeSH Terms

Interventions

Movement

Intervention Hierarchy (Ancestors)

Physiological Phenomena; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Oliver Martínez Pozas, PhD candidate

  Universidad Rey Juan Carlos (Madrid)

  PRINCIPAL INVESTIGATOR

• Eleuterio A. Sánchez Romero, PhD

  Universidad Europea de Madrid (Madrid)

  STUDY DIRECTOR

• Josué Fernández Carnero, PhD

  Universidad Rey Juan Carlos (Madrid)

  STUDY DIRECTOR

• Héctor Beltrán Alacreu, PhD

  Universidad de Castilla La-Mancha (Toledo)

  STUDY DIRECTOR

Central Study Contacts

Josué Fernández, PhD

CONTACT

+34 91 488 89 49; josue.fernandez@urjc.es

Oliver Martínez, PhD candidate

CONTACT

+34 691 78 14 59; o.martinezp.2018@alumnos.urjc.es

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: PhD

Model Details: Parallel assignment. Randomized, longitudinal, experimental, prospective, parallel and double-blind study with chronic low back pain adults.

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: June 25, 2021
• Study Start: September 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: June 25, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)