- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02560259
The Role of Referred Pain From the Retro Trochanteric Region in Patients With Knee Pain
The Role of Referred Pain From the Retro Trochanteric Region in Patients With Knee Pain. Prevalence, Interpretation and Management: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Knee pain is a great problem in the society. Besides obvious and known causes, for which there are increasing understanding and ways to treat, there is still a rather large group of patients in which the symptoms are not easily understood and harder to treat.
This group is often characterized by having symptoms ranging from months to years, having seen several physicians, gone through several x-rays/mri´s, and various treatment with no help.
The investigators find ever more suspicion towards specific mechanisms in the hip region as a source of knee pain. It is well known in pediatric medicine that children with serious disease in the hip often debut with knee pain. This relationship is not so well established in adults.
Pain in the lower extremity can arise from inflammation or strain of the retro trochanteric muscles, and/or more indirectly if these processes impact the sciatic nerve. The later explanation is commonly known as the piriformis syndrome.
Professor Oddmund Johansen has studied this type of pain extensively. In the later years he has found interest in patients with knee pain.
These patients will often have pain with deep palpation to the posterior hip region, when tightening the hip rotators with flexion and adduction, and they will often respond with pain relief, within minutes, when local anesthesia is placed on the distal attachment of the hip rotators on the posterior margin of the greater trochanter. Afterwards, lasting pain relief can be seen with a specified stretching regiment for these muscles.
The investigators will recruit suiting patients from a knee referral list. Inclusion will be based on clinical examination and whether they respond to the injection. After inclusion they will be scored with pain and quality of life forms, randomised in two groups, one with a stretching regime and one with conservative and symptomatic treatment.
There is interest in defining and quantifying this sub group of knee patients. They will be followed up after 3 months, with a new examination and scoring to evaluate the effect of the intervention.
The study will examine how the patients react and comply with the proposed diagnosis and treatment. A cost analysis will also be considered.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anders Hennig, Physician
- Phone Number: +4797650807
- Email: anders.hennig@unn.no
Study Contact Backup
- Name: Oddmund Johansen, Professor
- Phone Number: +4707766
- Email: oddmund.johansen@unn.no
Study Locations
-
-
-
Tromsø, Norway
- University Hospital of Northern Norway
-
Contact:
- Anders Hennig, Physician
- Phone Number: +4797650807
- Email: anders.hennig@unn.no
-
Contact:
- Oddmund Johansen, Professor
- Phone Number: +4707766
- Email: oddmund.johansen@unn.no
-
Principal Investigator:
- Anders Hennig, Physician
-
Sub-Investigator:
- Oddmund Johansen, Professor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Mental illness
- Failure to cooperate
- Not adequate Norwegian language skills
- Other well known disease explaining symptoms
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Physiotherapy Group
Physiotherapy
|
Physiotherapy
|
Placebo Comparator: Conservative group
Conservative treatment
|
Conservative treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain on VAS score
Time Frame: At 3 months
|
0 no pain, 10 worst possible pain
|
At 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
KOOS score subscales Pain
Time Frame: At 3 months
|
Standard scoring on the KOOS subscale of pain
|
At 3 months
|
KOOS score subscale Symptoms
Time Frame: At 3 months
|
Standard scoring on the KOOS subscale of symptoms
|
At 3 months
|
KOOS score subscale Function in daily living
Time Frame: At 3 months
|
Standard scoring on the KOOS subscale of Function of daily living
|
At 3 months
|
KOOS score subscale Knee-Related Quality of Life
Time Frame: At 3 months
|
Standard scoring on the KOOS subscale of Knee-Related Quality of Life
|
At 3 months
|
KOOS score subscale Function in Sports and Recreation
Time Frame: At 3 months
|
Standard scoring on the KOOS subscale of Function in Sports and Recreation
|
At 3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Working full time the last week
Time Frame: At 3months
|
Response yes or no to question if the participant worked full time last week
|
At 3months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Oddmund Johansen, Professor, University Hospital og North Nprway, ortopedic department
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015/157(REK)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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