Effect of Allium Cepa in the Management of Shoulder Pain Post Stroke

Bayero University Kano, Nigeria

Status and phase: Completed; Early Phase 1

Conditions: Stroke

Treatments: Biological: Phonophoresis of Allium Cepa Extract; Biological: Raw Mashed Allium Cepa Application; Biological: Topical App. of Allium Cepa Extract; Other: Standard Physiotherapy Group (SPG)

Study type: Interventional

Funder types: Other

Identifiers

NCT03468049

HMohammed

Details and patient eligibility

About

One of the disabling consequences of stroke is hemipleic shoulder pain. Hemiplegic shoulder pain could be most important hinderance to upper extremity function after stroke . Evidence for rehabilitation approaches for shuolder pain suggested diverse approaches with strong need for further studies. This study planned to investigate the effect of Allium Cepa in the management of shoulder pain post stroke using four arms of the studying with three intervention groups and control group All participants who met study inclusion criteria and gave their consent shall be assessed at baseline for impairment (Fugl Meyer Assessment), activity limitation (Brief Pain Inventory) and participation restrictions (Stroke Impact Scale)

Full description

Globally, stroke is the second most common cause of death and a major cause of disability. One of the disabling consequences of stroke is hemipleic shoulder pain which on its own could result in disability. Physical therapy is an integral part of post stroke rehabilitation, and plays an important role in the prevention and treatment of hemiplegic shoulder pain. Generally, patients with pain will most likely experience greater cognitive impairment and functional decline, lower quality of life, fatigue, depression and often poorly cooperate in rehabilitation. It was reported from a study that the ideal management of hemiplegic shoulder pain is to prevent it from happening in the first place, once the patient developed pain, resultant anxiety and over protection will follow. Hemiplegic shoulder pain can also interfere with arm recovery, reduce activity of daily living and markedly hinder rehabilitation.Similarly, a study have reported shoulder pain to cause considerable distress, discomfort, interference with rehabilitation, delay in discharge and that it is generally poorly managed. A recently updated Evidence-Based Review of Stroke Rehabilitation (EBRSR) on painful hemiplegic shoulder summarised 19 key points about painful hemiplegic shoulder; while all the 19 points are essential, the need for these study is closely related by some of these points these include Aggressive range of motion exercises (i.e. pullies) results in a markedly increased incidence of painful shoulder; a gentler range of motion program is preferred. Adding ultrasound treatments does not appear to improve shoulder range of motion, Treatment with surface neuromuscular electrical stimulation (NMES) early (< 6 months) post-stroke may reduce shoulder subluxation but not pain associated with shoulder hemiplegia. Surface NMES delivered after 6 months provides no additional benefits over conventional therapy on shoulder subluxation. Intramuscular NMES however, has been found to reduce shoulder pain up to 12 months post-therapy, Strapping/taping the hemiplegic shoulder does not appear to improve upper limb function, but may reduce pain, Further research is needed to determine the benefits of aromatherapy in combination with acupressure regarding its effects on reducing pain caused by shoulder hemiplegia and Massage therapy may reduce hemiplegic shoulder pain, anxiety, and other physiological functions (i.e. blood pressure, and heart rate) however, more research is still warranted. This study will therefore investigat the effect of Allium cepa(onion) in the management of shoulder pain post stoke.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:Participants who had hemiplegic shoulder pain after stroke with age range of 18 years and above who are able to express pain level and communicate in general

Exclusion Criteria:

1. Stroke survivors with significant cognitive impairment (< 18 on a mini mental scale) and language impairment that would prevent the patient from answering questions reliably.
2. Stroke survivors who had sustained shoulder pain caused by condition other than hemiplegia such as fracture, vertebral origin, dislocation, inflammatory arthritis (rheumatoid and gout) and fibromyalgia.
3. Participants who exhibit allergy to Allium Cepa (skin sensitivity or finds the odor offensive).
4. Participants who do not agree to use Allium Cepa

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 4 patient groups

Topical App. of Allium Cepa Extract

Experimental group

Description:

Intervention: 5mg of Allium Cepa Extract (Allium Cepa oil) will be applied on the shoulder joint of the participant, followed by kneading massage until the Allium Cepa oil deeply penetrate into the shoulder joint in addition to standard physiotherapy management of shoulder pain post stroke. Three times in a week for four weeks

Treatment:

Biological: Topical App. of Allium Cepa Extract

Other: Standard Physiotherapy Group (SPG)

Phonophoresis of Allium Cepa extract

Experimental group

Description:

Intervention: 5mg of Allium Cepa extract (Allium Cepa oil) would be applied on the shoulder joint of the participant, followed by phonophoresis using ultrasound set at at treatment parameter of pulse mode (50%), 1mHz transducer frequency and stroking technique of 1.5w/cm square for 5mins to allow deeper penetration of the Allium Cepa oilinto the joint in addition to standard physiotherapy management of shoulder pain post stroke.Three times in a week for four weeks

Treatment:

Biological: Phonophoresis of Allium Cepa Extract

Other: Standard Physiotherapy Group (SPG)

Raw mashed Allium Cepa Application

Experimental group

Description:

Intervention: 5g or a small size Raw Allium Cepa (onion)bulb will be cut into pieces and then mashed inside pestle and mortar, thereafter the Raw mashed Allium Cepa will then be applied on the surface of the shoulder joint of the participant and then secured with a gauze bandage for 2 hours to allow deeper penetrationin addition to standard physiotherapy management of shoulder pain post stroke. Three times in a week for four weeks

Treatment:

Biological: Raw Mashed Allium Cepa Application

Other: Standard Physiotherapy Group (SPG)

Standard physiotherapy group (SPG)

Active Comparator group

Description:

Participant in this group will be receiving standard physiotherapy management of shoulder pain post stroke. The standard physiotherapy management will divided into two forms of activities, the first approach is soft tissue manipulation using common massage medium in particular powder would be used in this study. The second approach is the use of therapeutic exercises and this therapeutic exercises will be categorized into three (basic level, intermediate level and advance level of shoulder joint exercises) depending on the stage of recovery of the participants. Three times in a week for four weeks

Treatment:

Other: Standard Physiotherapy Group (SPG)