NCT03586778

Brief Summary

The aim of this trial will be to examine the short and long term effectiveness of dry needling on pain, disability, and patient perceived improvements in patients with back pain attending physical therapy. The investigators hypothesize that patients who receive dry needling, manual therapy, and exercise will achieve greater reductions in pain and disability in the short (6 weeks) and long term (6 and 24 months) compared to those who receive just manual therapy, and exercise.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 16, 2018

Completed
2 years until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2020

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

27 days

First QC Date

June 26, 2018

Last Update Submit

July 28, 2020

Conditions

Back Pain

Keywords

Back PainDry Needling

Outcome Measures

Primary Outcomes (1)

  • Change from baseline of Modified Oswestry Disability Index(MODI)

    Modified Oswestry Disability Index (MODI) is one of the modified versions of the Oswestry Disability Index. It consists of 10 items addressing different aspects of function. Each item is scored from 0 to 5, with higher values representing greater disability. The total score is multiplied by 2 and expressed as a percentage.

    baseline, six weeks, six months and 24 months

Secondary Outcomes (4)

  • Change from baseline of Visual Analog Scale (VAS)

    baseline, six weeks, six months and 24 months

  • Fear Avoidance Belief Questionnaire ( FABQ)

    baseline, six weeks, six months and 24 months

  • Global Rating of Change (GROC)

    six weeks, six months and 24 months

  • STarT Back

    baseline, six weeks, six months and 24 months

Study Arms (2)

MTEX-DN

EXPERIMENTAL

dry needling, manual therapy, and therapeutic exercise

Other: dry needlingOther: manual therapyOther: therapeutic exercise

MTEX

ACTIVE COMPARATOR

manual therapy and therapeutic exercise

Other: manual therapyOther: therapeutic exercise

Interventions

dry needlingOTHER

Dry Needling targeting the posterior musculature of the thoraco-lumbar spine and hips

MTEX-DN
manual therapyOTHER

Manual Therapy(mobilization/ manipulation) to address joint mobility of the thoraco-lumbar spine and hips

MTEXMTEX-DN
therapeutic exerciseOTHER

Exercise designed to improve performance of the paraspinal and abdominal musculature as well as the hip musculature. The exercise portion will also include a stretching program targeting the trunk and hip muscles which have been placed in a shortened position as a result of poor postures.

MTEXMTEX-DN

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary complaint of back pain
  • Modified Oswestry Disability Index \> 10 points=20%

You may not qualify if:

  • Red flags noted in the patient's Low Back Medical Screening (i.e. tumor, fracture, metabolic diseases, Rheumatoid Arthritis, prolonged history of steroid use, pregnancy, ankylosing spondylitis, cauda equina).
  • Use of high doses of blood thinners
  • Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the lower extremity, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes), etc.
  • Workers compensation or pending legal action regarding their back pain
  • Insufficient English language skills to complete all questionnaires
  • Inability to comply with treatment and follow-up schedule

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Concord Hospital Rehabilitation Services

Concord, New Hampshire, 03301, United States

Location

MeSH Terms

Conditions

Back Pain

Interventions

Dry NeedlingMusculoskeletal ManipulationsExercise Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationAftercareContinuity of Patient CarePatient Care

Study Officials

  • Sebastian DG Sabadis, MS

    Concord Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessment will be performed by an individual blind to group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist

Study Record Dates

First Submitted

June 26, 2018

First Posted

July 16, 2018

Study Start

July 1, 2020

Primary Completion

July 28, 2020

Study Completion

July 28, 2020

Last Updated

July 29, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)