The Role of Referred Pain From the Retro Trochanteric Region in Patients With Knee Pain
Primary Purpose
Referred Pain
Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Physiotherapy
Conservative treatment
Sponsored by
About this trial
This is an interventional treatment trial for Referred Pain focused on measuring knee pain
Eligibility Criteria
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
Sites / Locations
- University Hospital of Northern Norway
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Physiotherapy Group
Conservative group
Arm Description
Physiotherapy
Conservative treatment
Outcomes
Primary Outcome Measures
Pain on VAS score
0 no pain, 10 worst possible pain
Secondary Outcome Measures
KOOS score subscales Pain
Standard scoring on the KOOS subscale of pain
KOOS score subscale Symptoms
Standard scoring on the KOOS subscale of symptoms
KOOS score subscale Function in daily living
Standard scoring on the KOOS subscale of Function of daily living
KOOS score subscale Knee-Related Quality of Life
Standard scoring on the KOOS subscale of Knee-Related Quality of Life
KOOS score subscale Function in Sports and Recreation
Standard scoring on the KOOS subscale of Function in Sports and Recreation
Full Information
NCT ID
NCT02560259
First Posted
May 11, 2015
Last Updated
September 24, 2015
Sponsor
University Hospital of North Norway
1. Study Identification
Unique Protocol Identification Number
NCT02560259
Brief Title
The Role of Referred Pain From the Retro Trochanteric Region in Patients With Knee Pain
Official Title
The Role of Referred Pain From the Retro Trochanteric Region in Patients With Knee Pain. Prevalence, Interpretation and Management: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of North Norway
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Referred Pain
Keywords
knee pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Physiotherapy Group
Arm Type
Active Comparator
Arm Description
Physiotherapy
Arm Title
Conservative group
Arm Type
Placebo Comparator
Arm Description
Conservative treatment
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
Physiotherapy
Intervention Type
Other
Intervention Name(s)
Conservative treatment
Intervention Description
Conservative treatment
Primary Outcome Measure Information:
Title
Pain on VAS score
Description
0 no pain, 10 worst possible pain
Time Frame
At 3 months
Secondary Outcome Measure Information:
Title
KOOS score subscales Pain
Description
Standard scoring on the KOOS subscale of pain
Time Frame
At 3 months
Title
KOOS score subscale Symptoms
Description
Standard scoring on the KOOS subscale of symptoms
Time Frame
At 3 months
Title
KOOS score subscale Function in daily living
Description
Standard scoring on the KOOS subscale of Function of daily living
Time Frame
At 3 months
Title
KOOS score subscale Knee-Related Quality of Life
Description
Standard scoring on the KOOS subscale of Knee-Related Quality of Life
Time Frame
At 3 months
Title
KOOS score subscale Function in Sports and Recreation
Description
Standard scoring on the KOOS subscale of Function in Sports and Recreation
Time Frame
At 3 months
Other Pre-specified Outcome Measures:
Title
Working full time the last week
Description
Response yes or no to question if the participant worked full time last week
Time Frame
At 3months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anders Hennig, Physician
Phone
+4797650807
Email
anders.hennig@unn.no
First Name & Middle Initial & Last Name or Official Title & Degree
Oddmund Johansen, Professor
Phone
+4707766
Email
oddmund.johansen@unn.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oddmund Johansen, Professor
Organizational Affiliation
University Hospital og North Nprway, ortopedic department
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Northern Norway
City
Tromsø
Country
Norway
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anders Hennig, Physician
Phone
+4797650807
Email
anders.hennig@unn.no
First Name & Middle Initial & Last Name & Degree
Oddmund Johansen, Professor
Phone
+4707766
Email
oddmund.johansen@unn.no
First Name & Middle Initial & Last Name & Degree
Anders Hennig, Physician
First Name & Middle Initial & Last Name & Degree
Oddmund Johansen, Professor
12. IPD Sharing Statement
Citations:
PubMed Identifier
19263036
Citation
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.
Results Reference
result
PubMed Identifier
21678093
Citation
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.
Results Reference
result
PubMed Identifier
19396428
Citation
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.
Results Reference
result
PubMed Identifier
12855348
Citation
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.
Results Reference
result
Learn more about this trial
The Role of Referred Pain From the Retro Trochanteric Region in Patients With Knee Pain
We'll reach out to this number within 24 hrs