NCT02560259

Brief Summary

The role of referred pain from the retro trochanteric region, in patients with knee pain. Defining and quantifying this sub group of knee patients in the investigators list of refered knee patients. Evaluating the effect of treatment. A randomized trial.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

May 11, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 25, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

September 25, 2015

Status Verified

September 1, 2015

Enrollment Period

10 months

First QC Date

May 11, 2015

Last Update Submit

September 24, 2015

Conditions

Referred Pain

Keywords

knee pain

Outcome Measures

Primary Outcomes (1)

  • Pain on VAS score

    0 no pain, 10 worst possible pain

    At 3 months

Secondary Outcomes (5)

  • KOOS score subscales Pain

    At 3 months

  • KOOS score subscale Symptoms

    At 3 months

  • KOOS score subscale Function in daily living

    At 3 months

  • KOOS score subscale Knee-Related Quality of Life

    At 3 months

  • KOOS score subscale Function in Sports and Recreation

    At 3 months

Other Outcomes (1)

  • Working full time the last week

    At 3months

Study Arms (2)

Physiotherapy Group

ACTIVE COMPARATOR

Physiotherapy

Other: Physiotherapy

Conservative group

PLACEBO COMPARATOR

Conservative treatment

Other: Conservative treatment

Interventions

PhysiotherapyOTHER

Physiotherapy

Physiotherapy Group
Conservative treatmentOTHER

Conservative treatment

Conservative group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Knee pain
  • Failure to understand the pain with more conventional diagnosis
  • Symptoms and retrotrochanteric pain with examination
  • Pain relief with retro trochanteric local anaesthetic injection

You may not qualify if:

  • Mental illness
  • Failure to cooperate
  • Not adequate Norwegian language skills
  • Other well known disease explaining symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Northern Norway

Tromsø, Norway

Location

Related Publications (4)

  • Meknas K, Kartus J, Letto JI, Flaten M, Johansen O. A 5-year prospective study of non-surgical treatment of retro-trochanteric pain. Knee Surg Sports Traumatol Arthrosc. 2009 Aug;17(8):996-1002. doi: 10.1007/s00167-009-0750-z. Epub 2009 Mar 5.

    PMID: 19263036RESULT

  • Meknas K, Johansen O, Kartus J. Retro-trochanteric sciatica-like pain: current concept. Knee Surg Sports Traumatol Arthrosc. 2011 Nov;19(11):1971-85. doi: 10.1007/s00167-011-1573-2. Epub 2011 Jun 16.

    PMID: 21678093RESULT

  • Meknas K, Kartus J, Letto JI, Christensen A, Johansen O. Surgical release of the internal obturator tendon for the treatment of retro-trochanteric pain syndrome: a prospective randomized study, with long-term follow-up. Knee Surg Sports Traumatol Arthrosc. 2009 Oct;17(10):1249-56. doi: 10.1007/s00167-009-0787-z. Epub 2009 Apr 18.

    PMID: 19396428RESULT

  • Meknas K, Christensen A, Johansen O. The internal obturator muscle may cause sciatic pain. Pain. 2003 Jul;104(1-2):375-80. doi: 10.1016/s0304-3959(03)00045-9.

    PMID: 12855348RESULT

MeSH Terms

Conditions

Pain, Referred

Interventions

Physical Therapy ModalitiesConservative Treatment

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Oddmund Johansen, Professor

    University Hospital og North Nprway, ortopedic department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anders Hennig, Physician

CONTACT

+4797650807anders.hennig@unn.no

Oddmund Johansen, Professor

CONTACT

+4707766oddmund.johansen@unn.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 11, 2015

First Posted

September 25, 2015

Study Start

October 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2017

Last Updated

September 25, 2015

Record last verified: 2015-09

Locations

NO(1)