AzTrials
AzTrials

Piriformis SyndromeNCT04842656

Soft Tissue Techniques in Piriformis Syndrome

A study testing Post isometric relaxation and Active release technique alongwith conventional treatment in people with Piriformis Syndrome, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of the study is to compare the effects of active release technique and post isometric relaxation in patients with piriformis syndrome on pain, hip internal rotation range of motion and functional disability. A randomized clinical trial was conducted at Shifa Intl. Hospital, Islamabad. Read more about this study

Who is it for?
Ages 35 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Piriformis Syndrome
What is being tested?
Post isometric relaxation and Active release technique alongwith conventional treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 sitePakistan
Study dates
30 Jun 2020to 26 Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Chronic pain in the buttock and hip area
  • Tenderness to palpation over the sciatic notch
  • Positive FABER (flexion, abduction, external rotation),FAIR (flexion, adduction, internal rotation) maneuvers.

Who cannot join

  • Malignancies
  • History of steroid therapy
  • Rheumatoid arthritis/ Osteoarthritis
  • Pain medications/ muscle relaxants
  • Osteoporosis
  • Fracture of femur and hip joint dislocation

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Shifa International Hospital

    Islamabad, 44000

Other trials in Pakistan

About this study

Official title: Comparison of Active Release Technique and Post Isometric Relaxation in Patients With Piriformis Syndrome

The purpose of the study is to compare the effects of active release technique and post isometric relaxation in patients with piriformis syndrome on pain, hip internal rotation range of motion and functional disability. A randomized clinical trial was conducted at Shifa Intl. Hospital, Islamabad. The sample size was 26 calculated through open-epi tool but were recruited 30. The participants were divided into two interventional groups each having 15 participants. The study duration was six months. Sampling technique applied was purposive sampling for recruitment and group randomization using sealed envelope method. Only 35 to 55 years participants with diagnosed piriformis syndrome were included in this study. Tools used in this study are Goniometer, Visual Analogue Scale and lower extremity functional scale. Data was collected at baseline, 3 weeks after sessions and after one month follow up. Data was analyzed through SPSS version 20.

Read the detailed description

Piriformis syndrome is caused by prolonged or excessive contraction of the piriformis muscle. Because of the close proximity to the sciatic nerve, piriformis syndrome is associated with pain in the buttocks, hips, and lower limbs. Yeoman was the first to describe pain in the sciatic distribution to piriformis syndrome. Many synonyms for the condition are used in the literature, such as ''deep gluteal syndrome'' and ''pelvic outlet syndrome''. It has been suggested that piriformis syndrome is responsible for 5-6% of cases of sciatica. In the majority of cases, piriformis syndrome occurs in middle-aged patients (mean age 38 year). The ratio of female to male patients with piriformis syndrome has been reported as 6:1.

Three specific conditions may contribute to piriformis syndrome:

  1. myofascial referred pain from trigger points in the piriformis muscle
  2. adjacent muscles, nerve and vascular entrapment by the piriformis muscle at the greater sciatic foramen
  3. dysfunction of the sacroiliac joint. Myofascial pain syndrome in the piriformis muscle is well recognized. Gluteal pain is reported to be observed in 97.9% of cases, pain (and paresthesias) in the back, groin, perineum, buttocks, hip, back of the thigh (81.9%),calf (59%),foot, in the rectum (during defecation), and in the area of the coccyx. Low back pain is reported to be observed in 18.1% of cases. Intense pain will occur when the patient sits or squats. Nevertheless, true neurologic findings are not usually present in piriformis syndrome and sensory deficits may be completely absent.

There is no gold standard in diagnosing piriformis syndrome. The physical examination may reveal several of the following well-described signs:

  • The piriformis sign, (which presents as tonic external rotation of the affected lower extremity) is reported to be observed in 38.5% of the patients.
  • Freiberg's sign involves pain on passive forced internal rotation of the hip in the supine position, thought to result from passive stretching of the piriformis muscle and pressure on the sciatic nerve at the sacrospinous ligament. This test is positive in 56.2% of the patients.
  • Pace's sign consists of pain and weakness on resisted abduction and external rotation of the thigh in a sitting position . A positive test is reported to occur in 46.5% of the patient.
  • Lasegue's sign involves pain on the affected side on voluntary adduction, flexion, and internal rotation.
  • Beatty's maneuver is an active test that involves elevation of the flexed leg on the painful side while the patient lies on the asymptomatic side. Abducting the thigh to raise the knee off the table elicits deep buttock pain in patients with piriformis muscle but back and leg pain in those with lumbar disk disease.
  • The Hughes Test (external isometric rotation of the affected lower extremity following maximal internal rotation) may also be positive in piriformis syndrome.
  • Gluteal atrophy may be present.Sacroiliac tenderness is reported to be observed in 38.5% of the patients.

Piriformis syndrome causing sciatica usually responds to conservative treatments, including physical therapy, lifestyle modification, pharmacological agents (non-steroidal anti-inflammatory agents, muscle relaxants, and neuropathic pain medication) and psychotherapy. Physiotherapy management for piriformis syndrome includes application of heat therapy and ultrasound therapy in conjunction with stretching of piriformis muscle shows good effect on treatment. Also manual therapy approaches like myofascial release (MFR), muscle energy technique (MET), Active release technique shows beneficial effect on the treatment of soft tissue. The last option is surgical intervention which involves endoscopic decompression of sciatic nerve.

The Active release technique (ART) is a manual therapy used to recover function of soft tissue and in many ways similar to traditional 'Pin and stretch' techniques. Technique works on a variety of muscle, tendon, ligament, fascia and nerve tissues. In this technique deep pressure is applied over the tender point in a shortened position of the muscle and then patient is asked to actively take it in an opposite lengthened position. This will break the adhesions and restores the proper texture, elasticity and functions of soft tissues. There are a variety of studies that imply the value of ART as a treatment method for soft tissue injuries. ART has been used to treat nerve entrapment, tendinopathy, muscle strain, snapping hip syndrome, lateral epicondylitis, impaired range of motion, overuse syndrome, and improve performance and contributed to faster return to activity and decreased treatment time.

Muscle energy technique (MET) is an active muscle based treatment approach that involves the voluntary contraction of a subject's muscle(s) in a precisely controlled direction, against a counterforce provided by the therapist. The MET may be used to decrease pain, stretch tight muscles and fascia, reduce muscle tonus, improve local circulation, strengthen weak musculature and mobilize joint restrictions. The MET is used for achieving tonus release in a muscle before stretching via introduction of an isometric contraction to the affected muscle producing post isometric relaxation. Post isometric relaxation (PIR) is a MET used to relax and lengthen a hypertonic and shortened muscle. This gentle stretching technique is typically used on postural muscles. These muscles often become short and tight and can lead to muscle imbalances. This can limit range of motion and cause joint restrictions.

The effects of ART on gluteus medius for chronic lower back pain and concluded that ART was effective in reducing lower back pain.

ART for ITB syndrome and results showed that ART decreases pain and improves function.

The effects of Neuromuscular therapy and ART on piriformis tightness and concluded that significant improvement was observed in the VAS score and ROM in ART group.

Compared the effectiveness of ART with mulligan bent leg raise for hamstring tightness and concluded that ART was better in improving flexibility and ROM of hamstring.

Compared post isometric relaxation with stretching on piriformis syndrome and concluded that PIR technique group significantly improved in all outcome measures (pain, ROM).

The effects of PIR technique on myofascial tightness of lumbo-pelvic musculature in patients with chronic low back pain and concluded marked improvement in pain and functional disability.

Compared PIR technique with high velocity low amplitude techniques and concluded that both of the techniques are equally effective in managing low back pain.

Compared post isometric relaxation and reciprocal inhibition and concluded that post isometric relaxation is more effective in treating piriformis syndrome than reciprocal inhibition and proposed to follow further in chronic piriformis syndrome.

Currently there is little evidence of relative effects of Active release technique and post isometric relaxation in piriformis syndrome. Both techniques are found to be effective individually in different conditions but no research has been done yet on comparison of active release technique with muscle energy techniques like PIR in piriformis syndrome. Studies of ART on hamstring tightness shows significant immediate effects but the study was on healthy subjects. Effectiveness of ART is evident by one another study but only immediate effects were analyzed. Thus, effective long term follow up is lacking in literature. This present research will fill the gaps by studying the effects of ART and PIR in chronic piriformis syndrome and will help the clinicians with an alternative treatment approach

Being tested
Post isometric relaxation, Active release technique alongwith conventional treatment
Medical subject headings
Piriformis Muscle Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Post isometric relaxationOther

    Patients in group B will receive post isometric relaxation technique. Patient lying in supine position, with the treated leg is placed into flexion at the hip and knee, so that the foot rests on the table lateral to the contra lateral knee (the leg on the side to be treated is crossed over the other). Therapist places one hand on the contra lateral ASIS to prevent pelvic motion, while the other hand is placed against the lateral flexed knee as this is pushed into resisted abduction to contract piriformis (PIR MET). The starting position will be the 1st sign of resistance towards end range. Therapist Force will be same as patient's force. Initial effort is approximately 20% of patient's strength. Duration of contraction is 7-10 seconds with three repetitions

  • Active release technique alongwith conventional treatmentOther

    Patients in Group A will receive active release technique.ART will be applied with patient in prone lying, knee flexed at 90. The therapist will place his elbow tip on taut band of piriformisand direct pressure isapplied, patient is then asked to do internal rotation of hip, in order to achieve lengthening of the muscle. This will be repeated 5-7 times.

Study groups in NCT04842656
Study groupRoleWhat they receive
Active release technique alongwith conventional treatmentExperimentalPatients in Group A will receive active release technique. ART will be applied with patient in prone lying, knee flexed at 90. The therapist will place his elbow tip on taut band of piriformis and direct pressure is applied, patient is then asked to do internal rotation of hip, in order to achieve lengthening of the muscle. This will be repeated 5-7 times(22).
Receives: Other: Active release technique alongwith conventional treatment
Post isometric relaxation alongwith conventional treatmentExperimentalPatients in group B will receive post isometric relaxation technique. Patient lying in supine position, with the treated leg is placed into flexion at the hip and knee, so that the foot rests on the table lateral to the contra lateral knee (the leg on the side to be treated is crossed over the other). Therapist places one hand on the contra lateral ASIS to prevent pelvic motion, while the other hand is placed against the lateral flexed knee as this is pushed into resisted abduction to contract piriformis (PIR MET). The starting position will be the 1st sign of resistance towards end range. Therapist Force will be same as patient's force. Initial effort is approximately 20% of patient's strength. Duration of contraction is 7-10 seconds with three repetitions(32)
Receives: Other: Post isometric relaxation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analogue Scale

    It is used to measure the intensity or frequency of pain. It ranges on a scale from 0 to 10.

    Measured: 6 months

  2. Goniometer

    Goniometer is an efficient tool to measure hip range of motion. It measures an angle from 0 to 180.

    Measured: 6 months

  3. Lower Extremity Functional Scale

    It is a questionnaire containing 20 questions about a persons ability to perform everyday tasks. It minimum score is 0 and maximum score is 80

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2021
  2. Study start30 Jun 2020
  3. Primary completion20 Jan 2021
  4. Study completion26 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Comparison of Active Release Technique and Post Isometric Relaxation in patients with Piriformis Syndrome
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04842656
Sponsor's protocol ID
REC/00768 Attiq Ur Rehman
Status last verified
Sep 2021
First submitted
10 Apr 2021
Last updated
20 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Parziale JR, Hudgins TH, Fishman LM. The piriformis syndrome. Am J Orthop (Belle Mead NJ). 1996 Dec;25(12):819-23.

    PubMed 9001677
  • Yeoman W. The Relation Of Arthritis Of The Sacro-Iliac Joint To Sciatica, With An Analysis Of 100 Cases. The Lancet. 1928;212(5492):1119-23.

  • Hopayian K. Sciatica in the community--not always disc herniation. Int J Clin Pract. 1999 Apr-May;53(3):197-8.

    PubMed 10665132
  • Reichel G, Gaerisch F Jr. [Piriformis syndrome. A contribution to the differential diagnosis of lumbago and coccygodynia]. Zentralbl Neurochir. 1988;49(3):178-84. German.

    PubMed 2977249
  • Benson ER, Schutzer SF. Posttraumatic piriformis syndrome: diagnosis and results of operative treatment. J Bone Joint Surg Am. 1999 Jul;81(7):941-9.

    PubMed 10428125
  • Papadopoulos EC, Khan SN. Piriformis syndrome and low back pain: a new classification and review of the literature. Orthop Clin North Am. 2004 Jan;35(1):65-71. doi: 10.1016/S0030-5898(03)00105-6.

    PubMed 15062719
  • Kirkaldy-Willis WH, Hill RJ. A more precise diagnosis for low-back pain. Spine (Phila Pa 1976). 1979 Mar-Apr;4(2):102-9. doi: 10.1097/00007632-197903000-00003.

    PubMed 162546
  • Steiner C, Staubs C, Ganon M, Buhlinger C. Piriformis syndrome: pathogenesis, diagnosis, and treatment. J Am Osteopath Assoc. 1987 Apr;87(4):318-23. No abstract available.

    PubMed 3583849
  • Pace JB. Commonly overlooked pain syndromes responsive to simple therapy. Postgrad Med. 1975 Oct;58(4):107-13. doi: 10.1080/00325481.1975.11714172. No abstract available.

    PubMed 1099564
  • Blaser-Sziede R. Piriformissyndrom-kritische Beurteilung der Literatur und Diskussion der klinischen Zusammenhänge. manuelletherapie. 2006;10(04):159-69

  • Benzon HT, Katz JA, Benzon HA, Iqbal MS. Piriformis syndrome: anatomic considerations, a new injection technique, and a review of the literature. Anesthesiology. 2003 Jun;98(6):1442-8. doi: 10.1097/00000542-200306000-00022.

    PubMed 12766656
  • Hopayian K, Song F, Riera R, Sambandan S. The clinical features of the piriformis syndrome: a systematic review. Eur Spine J. 2010 Dec;19(12):2095-109. doi: 10.1007/s00586-010-1504-9. Epub 2010 Jul 3.

    PubMed 20596735
  • Durrani Z, Winnie AP. Piriformis muscle syndrome: an underdiagnosed cause of sciatica. J Pain Symptom Manage. 1991 Aug;6(6):374-9. doi: 10.1016/0885-3924(91)90029-4.

    PubMed 1880438
  • Freiberg AH. Sciatic pain and its relief by operations on muscle and fascia. Archives of Surgery. 1937;34(2):337-50

  • Fishman SM, Caneris OA, Bandman TB, Audette JF, Borsook D. Injection of the piriformis muscle by fluoroscopic and electromyographic guidance. Reg Anesth Pain Med. 1998 Nov-Dec;23(6):554-9. doi: 10.1016/s1098-7339(98)90080-3.

    PubMed 9840849

Questions about this trial

What is this clinical trial studying?

A study testing Post isometric relaxation and Active release technique alongwith conventional treatment in people with Piriformis Syndrome, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogue Scale (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04842656, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in