Investigating the Effects of a Spinal Mobilisation Intervention in People With Lower Back Pain

NCT04012970 | Completed Results

• 1 other identifier: PILOT_LBP_1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to measure and analyse the effect of a spinal mobilisation intervention on muscle tissue quality in people with lower back pain. The mobilisation intervention will be compared to a control with participants taking part in both conditions for a factorial, within-subject repeated measures study. The study will analyse lumbar muscle response to the manual intervention and analyse the potential influence of anthropometric measures of participants. The study hypothesises a decrease in lumbar stiffness post the intervention, compared to the control session.

Conditions

Lower Back Pain

Keywords

lower back pain; myometer; muscle stiffness; spinal mobilisations

Outcome Measures

Primary Outcomes (2)

• Intervention Erector Spinae Stiffness Change

  Stiffness values measured before and after 30 minute spinal mobilisation intervention. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. Recorded 3 times and mean value used for analysis.

  Change in muscle stiffness immediately after the 30 minute spinal mobilisation intervention.

• Control Erector Spinae Stiffness Change.

  Stiffness values measured before and after 30 minute control lying still. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. Recorded 3 times and mean value used for analysis.

  Change in muscle stiffness immediately after the 30 minute control session (lying still).

Secondary Outcomes (4)

• Intervention Erector Spinae Tone Change

  Change in muscle tone immediately after the 30 minute spinal mobilisation intervention.

• Control Erector Spinae Tone Change

  Change in muscle tone immediately after the 30 minute control session (lying still).

• Intervention Erector Spinae Elasticity Change

  Change in muscle elasticity immediately after the 30 minute spinal mobilisation intervention.

• Control Erector Spinae Elasticity Change

  Change in muscle elasticity immediately after the 30 minute control session (lying still).

Study Arms (2)

A - Intervention then control

EXPERIMENTAL

Intervention (30 minutes spinal mobilisations) received in first session, then control (30 minutes lying still) received in second session.

Other: Manual spinal mobilisations

B - Control then intervention

EXPERIMENTAL

Control (30 minutes lying still) received in first session, then intervention (30 minutes spinal mobilisations) received in second session.

Other: Manual spinal mobilisations

Interventions

Manual spinal mobilisations OTHER

A - Intervention then control; B - Control then intervention

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Suffering from lower back pain (region between 12th rib and gluteal folds), acute or chronic.

You may not qualify if:

• Respond positively to any absolute contraindications for spinal therapy, including:
• segment instability
• infectious disease
• osteomyelitis
• bone tumours
• neurological deficit
• upper motor neuron lesion
• spinal cord damage
• cervical arterial dysfunction
• Respond positively to relative contra-indications, excluded based on severity, including:
• osteoporosis
• spinal instability
• rheumatoid arthritis
• inflammatory disease
• active history of cancer

Sponsors & Collaborators

• Edinburgh Napier University: lead
• Scottish Hospital Endowments Research Trust: collaborator
• Pacla Medical Limited: collaborator

Study Sites (1)

Edinburgh Napier University

Edinburgh, EH11 4BN, United Kingdom

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Variation in level of lower back pain participants was low. Physical activity was not controlled and could be a factor in baseline muscle measurements.

Results Point of Contact

• Title: Rebecca Hamilton, PhD student
• Organization: Edinburgh Napier Univerisity

rebeccaisabel.hamilton@napier.ac.uk

0131 455

Study Officials

• Susan Brown

  Director of PhD Studies

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD student

Model Details: Cross-over study design, within-subject repeated measures (intervention versus no intervention).

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 9, 2019
• Study Start: July 1, 2016
• Primary Completion: September 30, 2016
• Study Completion: September 30, 2016
• Last Updated: November 29, 2019
• Results First Posted: November 29, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be entered when the study is completed and remain until 1 year post publication of summary data.
• Access Criteria: The anonymised participant data underlying the summary data published, will be shared on the Edinburgh Napier University Repository with submission of PhD thesis.

Locations

GB (1)