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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02560259
Other study ID # 2015/157(REK)
Secondary ID
Status Not yet recruiting
Phase N/A
First received May 11, 2015
Last updated September 24, 2015
Start date October 2015
Est. completion date August 2017

Study information

Verified date September 2015
Source University Hospital of North Norway
Contact Anders Hennig, Physician
Phone +4797650807
Email anders.hennig@unn.no
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date August 2017
Est. primary completion date August 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Physiotherapy
Physiotherapy
Conservative treatment
Conservative treatment

Locations

Country Name City State
Norway University Hospital of Northern Norway Tromsø

Sponsors (1)

Lead Sponsor Collaborator
University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

References & Publications (4)

Meknas K, Christensen A, Johansen O. The internal obturator muscle may cause sciatic pain. Pain. 2003 Jul;104(1-2):375-80. — View 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. Review. — View 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 — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Working full time the last week Response yes or no to question if the participant worked full time last week At 3months No
Primary Pain on VAS score 0 no pain, 10 worst possible pain At 3 months No
Secondary KOOS score subscales Pain Standard scoring on the KOOS subscale of pain At 3 months No
Secondary KOOS score subscale Symptoms Standard scoring on the KOOS subscale of symptoms At 3 months No
Secondary KOOS score subscale Function in daily living Standard scoring on the KOOS subscale of Function of daily living At 3 months No
Secondary KOOS score subscale Knee-Related Quality of Life Standard scoring on the KOOS subscale of Knee-Related Quality of Life At 3 months No
Secondary KOOS score subscale Function in Sports and Recreation Standard scoring on the KOOS subscale of Function in Sports and Recreation At 3 months No
See also
  Status Clinical Trial Phase
Completed NCT03926364 - Profile of Pain and Unpleasant Sensations in Patients With Referred Pain
Completed NCT03197337 - Is Localized Provoked Vulvodynia Caused by Laxity of the Utero-Sacral Ligaments? N/A