NCT02698072

Brief Summary

This study evaluates the combination of a therapeutic exercise program and dry needling in the treatment of knee osteoarthritis in older adults. Half of participants will receive therapeutic exercise program and dry needling in combination, while the other half will receive the same therapeutic exercise program and sham dry needling.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
12 days until next milestone

Study Start

First participant enrolled

March 15, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2016

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

December 12, 2017

Status Verified

December 1, 2017

Enrollment Period

3 months

First QC Date

January 4, 2016

Last Update Submit

December 11, 2017

Conditions

Knee Osteoarthritis

Keywords

StiffnessPainDisfunction

Outcome Measures

Primary Outcomes (1)

  • Western Ontario and McMaster Osteoarthritis Index (WOMAC) change assessment.

    The disease-specific questionnaire WOMAC is the most widely used instrument created and validated to evaluate both the symptomatology and function on osteoarthritis of the hip or knee.

    Base line, through study completion (3 months); and 3, 6 and 12 months follow-up

Secondary Outcomes (5)

  • Numeric Pain Rating Scale (NPRS)

    Base line, through study completion (3 months); ; and 3, 6 and 12 months follow-up

  • Barthel Index

    Base line, through study completion (3 months); and 3, 6 and 12 months follow-up

  • The Timed Up & Go Test

    Base line, through study completion (3 months); and 3, 6 and 12 months follow-up

  • Mini-Mental State Examination (MMSE)

    Base line and 12 months follow-up

  • EuroQol-5

    Base line, through study completion (3 months); and 3, 6 and 12 months follow-up

Other Outcomes (1)

  • Total number of falls change assessment.

    At Baseline and 1 year follow-up.

Study Arms (2)

Exercise and dry needling

EXPERIMENTAL

24 therapeutic exercise sessions (twice a week) of a land-based therapeutic exercise program consisting of aerobic exercise (20-25 min warm-up), lower limbs muscle strengthening (20-25 min) and lower limbs muscles stretching (10-15 min). 6 dry needling sessions (once a week) at all the pain points of the involved symptomatic lower limb/s using Hong's fast-in and fast-out technique with multiple rapid needle insertion.

Other: Therapeutic exerciseDevice: Dry needling

Exercise and sham dry needling

ACTIVE COMPARATOR

24 therapeutic exercise sessions (twice a week) of a land-based therapeutic exercise program consisting of aerobic exercise (20-25 min warm-up), lower limbs muscle strengthening (20-25 min) and lower limbs muscles stretching (10-15 min). 6 sham dry needling sessions (once a week) at all the pain points of the involved symptomatic lower limb/s using a park sham device consists of a base with a hole in the centre and sticky tape on the bottom. From the top of the base extends a double tube, continuing the central hole in the base.

Other: Therapeutic exerciseDevice: Sham dry needling

Interventions

Therapeutic exerciseOTHER

20-25 minutes aerobic exercise, 20-25 minutes strength exercise and 10-15 minutes stretch exercise.

Exercise and dry needlingExercise and sham dry needling
Dry needlingDEVICE

Dry needling needle AGUPUNT®

Exercise and dry needling
Sham dry needlingDEVICE

Sham dry needling DONGBANG-ACUPRIME®

Exercise and sham dry needling

Eligibility Criteria

Age62 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants aged 62 years and older.
  • Unilateral or bilateral disfunction and/or knee pain.
  • Primary knee ostearthritis fulfilling the American College of Rheumatology criteria for clinical and radiographic diagnostic.
  • At least 1 pain point elicited by palpation ipsilateral to the painful knee situated in a taut band of a skeletal muscle of the lower limbs, which usually have referred pain.

You may not qualify if:

  • Prior diagnoses or prescriptions in the medical record for myopathy or lumbo-sacral neuropathy.
  • Previous knee or hip joint replacement surgery of the affected joint.
  • Any other surgical procedure of the lower limbs in the previous 6 months.
  • Rheumatoid arthritis.
  • Initiation of opioid analgesia or cortico-steroid or analgesic injection intervention for hip or knee pain within the previous 30 days.
  • Alcohol or drugs consumption.
  • Uncontrolled hypertension or moderate to high risk for cardiac complications during exercise.
  • Conservative or invasive physical therapy (previous 6 months or during follow-up).
  • Taking antiaggregant or anticoagulant medications.
  • Physical impairments unrelated to the hip or knee preventing safe participation in exercise, walking or stationary cycling, such as: vision problems that affect mobility, body weight greater than 155 kg, neurogenic disorder, primary or significantly limiting back pain, advanced osteoporosis, or inability to walk 10 metres without an assistive device.
  • Inability to comprehend and complete study assessments or comply with study instructions.
  • Stated inability to attend or complete the proposed course of intervention and follow-up schedule.
  • Fibromyalgia syndrome or other altered affective/cognitive modulation processes of pain perception. .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Location

Related Publications (1)

  • Sanchez Romero EA, Fernandez-Carnero J, Calvo-Lobo C, Ochoa Saez V, Burgos Caballero V, Pecos-Martin D. Is a Combination of Exercise and Dry Needling Effective for Knee OA? Pain Med. 2020 Feb 1;21(2):349-363. doi: 10.1093/pm/pnz036.

    PMID: 30889250DERIVED

Related Links

MeSH Terms

Conditions

Osteoarthritis, KneePain

Interventions

Exercise TherapyDry Needling

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesComplementary Therapies

Study Officials

  • Eleuterio Atanasio Sánchez Romero, PT, MSc

    Universidad Rey Juan Carlos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 4, 2016

First Posted

March 3, 2016

Study Start

March 15, 2016

Primary Completion

June 16, 2016

Study Completion

June 1, 2017

Last Updated

December 12, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)