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ORIGINAL ARTICLE
Year : 2020  |  Volume : 20  |  Issue : 3  |  Page : 70-76

Effect of usual care versus accelerated rehabilitation on pain, range of motion, and function in patients with acute lateral ankle sprain: A pilot randomized clinical trial


Department of Physiotherapy, Lovely Professional University, Jalandhar, Punjab, India

Date of Submission20-Dec-2020
Date of Acceptance04-Feb-2021
Date of Web Publication02-Mar-2021

Correspondence Address:
Dr. Ammar Suhail
C/O Department of Physiotherapy, Lovely Professional University, Phagwara, Jalandhar - 144 411, Punjab
India
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DOI: 10.4103/sjsm.sjsm_40_20

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  Abstract 

Objective: The study's objective is to compare the effects of usual care group (UCG) versus accelerated rehabilitation group (ARG) on pain, range of motion (ROM), and function.
Methods: A total of thirty participants participated in the study; they were randomly allocated to two groups. They were allocated to either the UCG or AR group, and baseline characteristics were documented. Outcome measures were measured on two occasions, before starting treatment protocol and second after completing the study's protocol. The interventions were administered for 2 weeks, with four sessions a week for eight sessions. The principal outcome measure was pain measured using the Numeric Pain Rating Scale. The secondary outcome measure was ankle ROM and function measured on the Lower Extremity Functional Scale.
Results: Within-group analysis showed significant improvements in both the groups. There was no significant difference between the groups at the end of the treatment protocol.
Conclusion: The groups did not differ at 2 weeks postacute inversion ankle sprains in the measured outcome measures.

Keywords: Lateral ankle sprains, Protection, Rest, Ice, Compression, and Elevation therapy, rehabilitation


How to cite this article:
Sharma K, Quais S, Siddiqui A, Suhail A. Effect of usual care versus accelerated rehabilitation on pain, range of motion, and function in patients with acute lateral ankle sprain: A pilot randomized clinical trial. Saudi J Sports Med 2020;20:70-6

How to cite this URL:
Sharma K, Quais S, Siddiqui A, Suhail A. Effect of usual care versus accelerated rehabilitation on pain, range of motion, and function in patients with acute lateral ankle sprain: A pilot randomized clinical trial. Saudi J Sports Med [serial online] 2020 [cited 2021 May 6];20:70-6. Available from: https://www.sjosm.org/text.asp?2020/20/3/70/310622




  Introduction Top


Ankle sprains (ASs) are one of the most frequent ankle injuries among sedentary people and athletes.[1],[2] ASs are of two types: low and high ASs, the former being more common.[2],[3] Depending on the injury mechanism, we can differentiate low ASs as lateral ASs (LASs) or eversion ASs presenting as acute and chronic. Most commonly, LAS is caused by a combination of inversion and adduction of the foot.[1],[4],[5] LAS shows age- and gender-related differences, too, with the majority occurring among individuals under 35 years of age, most commonly in those aged 15–19 years.[2],[6]

LAS occurs one for every 10,000 people each day, constituting 7%–10% of all admissions to hospital emergency departments.[6] In other reports, the prevalence is estimated to be 7 LASs per 1000 exposures.[7] According to the severity of the injury, LAS is divided into three grades.[1] The most common ligaments which get injured are lateral ligament complex (i.e., anterior talofibular ligament [ATFL], calcaneofibular ligament, and posterior talofibular ligament); the ATFL is the first ligament to get sprained in most of the cases.[1],[7] Nearly, all ASs presenting in emergency departments are Grade 1 and Grade 2, with Grade 3, the minimum.[8] LAS is associated with high health-care costs and associated morbidity.[7],[8],[9],[10] Although benign, nearly 70% of patients report short- and long-term disability.[3],[7],[8],[11] Studies have focused on different intervention strategies to reduce disability and enhance return to activity.[8]

Ligament healing stages are the guide for choosing appropriate management strategies. Ligament healing is divided into three stages: (1) the inflammatory phase (until 10 days after trauma), (2) the proliferation phase (4th–8th week), and (3) the remodeling or maturation phase.[4] LAS's treatment strategies are based on stages of soft-tissue healing to decrease symptoms associated with LAS. Different management strategies (immobilization, cryotherapy, nonsteroidal anti-inflammatory drug, supervised physical therapy, braces, electrical stimulation, therapeutic ultrasound, manual therapy, and surgery) have been reported with variable efficacies.[1],[3],[4],[7],[8],[9],[10],[12],[13],[14],[15] Recently, the use of cryotherapy is rebutted during the stage of inflammation.[16] Over the year, there is a shift in the management strategy of LAS in the acute phase. Different acronyms such as Protection, Rest, Ice, Compression, and Elevation (PRICE) to Protection, Optimum Loading, Ice, Compression, and Elevation (POLICE) protocol and most recently to Protection, Education, Avoid Anti-Inflammatory Medications, Compression, and Elevation (PEACE) and Load, Optimism, Vascularization, and Exercise (LOVE) reflect the management strategies.[8],[15],[16],[17] The treatment strategies were designed using PRICE in the UCG and PEACE & LOVE in the ARG.

The study's primary aim was to determine which group (UCG vs. ARG) will have better reductions in pain posttreatment. The secondary aim was to study which group will show better improvement on disability and range of motion (ROM).


  Methods Top


Study design and randomization

The study was designed as a pilot clinical trial with two parallel treatment arms. The participants were randomly allocated to each treatment arm using block randomization. The person involved in randomization had no role in interventions and outcome assessment.

Participants

Patients presenting with acute ankle injuries to the Physiotherapy Outpatient Department, Lovely Professional University, Phagwara, India, were screened for inclusion in the study. The participants were included in the study based on clinical examination. They must have sustained the injury in <72 h before presentation to be included in the study. They were included if they were 18 years or older and should have an acute injury to the lateral ligament complex. The anterior drawer test must elicit pain and apprehension, and the patient must have painful ROM and swelling present on the lateral aspect of the ankle. The patients ought to have fluency in English, competent to provide informed consent, and should show a willingness to participate in the trial.

They were excluded from the trial if they were tested positive on Ottawa Ankle Rule or had any previous history of similar ankle injuries in the past. If they had a history of any vascular disorder or any previous surgery on the affected extremity or clinical examination, it was not LAS. The participant signed a written consent form before participating in the study. They were thoroughly explained about the study objectives. The participants signed informed consent; the inclusion was voluntary; the study's ethical standards were in accordance with the Declaration of Helsinki on Ethical Principles for Medical Research. The study was approved by the Institutional Ethics Committee (LPU/IEC/2019/03/10).

Procedure

On initial presentation to the clinic, baseline data were obtained and documented. After inclusion in the study, they were randomly allocated into parallel treatment arms. The randomization was done using block randomization to distribute participants in both the groups evenly. The participants were allocated to either the UCG or the ARG; baseline characteristics were assessed and documented. The outcomes' measurements were done on two occasions (pretreatment and posttreatment) on day 0 and day 14 after completing the intervention protocol. The total duration of interventions was 2 weeks, with four sessions in a week accounting for eight sessions distributed over 2 weeks for the ARG. The UCG participants got supervised intervention during the 1st week. In the 2nd week, they were instructed to and managed the injury at home. Participants' treatment continued after this duration though the data were not included in the present study.

Interventions

Participants assigned to UCG were given standard PRICE protocol, including protection, rest, cryotherapy compression through the bandage, and elevation. Instructions on expected recovery and weight-bearing status were discussed on the first visit. They were given a one-page written summary of instruction for essential management of the injury at home also.

The participants assigned to the ARG got treatment based on the PEACE and LOVE method and were divided into two phases. The first phase (Stage I) was 0–3 days, and the goal was to decrease pain and swelling. Each sitting lasted for nearly 30–45 min. The detailed protocol is highlighted in [Table 1]. Participants received interventions on Monday, Wednesday, Friday, and Saturday during the 2 weeks.
Table 1: Treatment protocols for UCG and ARG group

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Outcome measures

The primary outcome measure was pain as evaluated on NRS. The secondary outcome measures were ROM and the Lower Extremity Functional Scale (LEFS). Both the outcomes were assessed on two different time intervals.

Pain

The intensity of pain was measured with the Numeric pain rating scale (NRS). The scale has 11 points ranging from “0” representing no pain to “10” representing the highest pain. The MCID of NRS is reported as 1.3 and 2.1 points in neck pain patients.[18] There are no studies reporting MCID in inversion AS patients.

Function

The function was assessed using the LEFS. It is a questionnaire containing 20 questions about a person's ability to perform everyday tasks related to the lower limb. Each question can have scores from 0 to 4, with 0 denoting extremely difficulty and 4 indicating no difficulty in performing the specific tasks. The lower the score, the greater is the disability. The LEFS is reported to have good construct validity and excellent test–retest reliability (r = 0.94 at 95% confidence interval [CI]). The MCID for LEFS is 9 scale points (90% CI).[19] The MDC is reported between 8.1 and 15.3 (90% CI) across different reassessment intervals in a wide range of patient populations.[20]

Range of motion

Active ankle ROM was measured using a universal goniometer. The therapist aligned the goniometer's axis over the lateral malleolus, the proximal arm on the fibula's midline, and the distal arm parallel to the fifth metatarsal. The patient performed ankle ROM (plantar and dorsiflexion), and the readings were noted. The reliability of universal goniometer ranges from low to good.[21]


  Results Top


Thirty participants were included in the final data analysis [Figure 1]. Participants' characteristics and baseline outcome measurements are highlighted in [Table 2]. There was no significant difference between the two treatment arms at the starting of the trial.
Figure 1: CONSORT flow diagram of the study

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Table 2: Baseline characteristics of participants

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Inferential analysis

The primary as well as secondary outcome measures were analyzed using Student's t-test. For comparison of between-group measures and paired samples, t-test was used, and for comparison of pre- and postoutcome measures within the group, independent t-test was used.

Within-group analysis

Within-group analysis for UCG showed a significant change in measured parameters pre and post. The within-group differences are highlighted in [Table 3]. The ARG showed similar results with significant changes between the outcomes postintervention. The analysis for ARG is highlighted in [Table 4].
Table 3: Within-group pre and post-intervention differences in usual care group

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Table 4: Within-group pre and post-intervention differences in the accelerated rehabilitation group

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Between-group analysis

The difference between the two groups was not significant for all the desired outcomes. The effect sizes were also small for the measured outcomes. Pain scores had a mean difference of 0.733, which was not significant, although each group had significant improvement in pain scores. The decrease in pain intensity in both the groups was more than the reported MCID (more than 2.1 points) for NRS. Similarly, LEFS scores did not show any significant difference, though differences between pre- and postreadings were above the reported MDC values for the scale. ROM did not show any significant difference between the two groups. The values of all the outcome measures are highlighted in [Table 5].
Table 5: Between-group differences among the primary and secondary outcome measures

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  Discussion Top


The study's main findings were showed no significant difference in outcomes 14 days postacute injury between UCG and ARG. There was a significant difference in all outcomes within the group. The findings were expected, considering the short time frame of the interventions. Within-group differences were significant for all the outcome measures.

Pain

One of the primary goals of physiotherapy interventions in the acute phase is to reduce pain. However, there was no difference between the group's postintervention in pain scores, but both the groups had a significant decrease in pain scores. The UCG had a more significant reduction in self-reported pain. The pain reduction through ice is a contentious issue. The published literatures to date propose different mechanisms: reduction in nerve conduction, the antinociceptive effect on the gate control mechanism, reduction in muscle spasm, and activating a sympathetic vasoconstrictive reflex.[22],[23] In the present study, we could not ascertain the exact mechanism resulting in pain reduction. The pain reductions in the ARG could be attributed to exercise-induced hypoalgesia (EIH). The EIH mechanism is poorly understood; two hypotheses are usually proposed: (1) exercise increases serum concentrations of endocannabinoid, and (2) central opioid systems are activated by increased discharges from mechanosensitive afferent nerve fibers A-delta and IV (C) arising from skeletal muscles.[24],[25]

Our study results are similar to the study conducted by Wayne;[26] they compared PRICE protocol to multimodal physiotherapy. They could not demonstrate a significant difference between pain scores in the two groups. Our study, though, did not aim at comparing supervised treatment versus the usual care. A study using a similar treatment strategy as the present study reported homogeneous findings; no difference in pain scores was found in the UCG receiving PRICE protocol versus a supervised tailored treatment protocol.[8] Our findings were not in agreement with the study conducted by Cleland et al.;[18] they reported a significant difference in pain scores between manual therapy and ARG versus supervised home exercise program. Our study did not use any mobilization and manipulation, hence possible nonsignificant pain reductions.

Range of motion

The ROM (DF and PF) improved in both the groups postintervention. ROM was expected to be better in the ARG, though there was no difference between the two treatment arms. There could be two reasons for this discrepant result. First, the short study duration, so we could not observe any significant difference at 14 days of the postacute injury. Second, the restriction in ROM is not a true restriction. It is documented that a severe, distended joint will cause a musculature reflex inhibition around the ankle, known as an arthrogenic muscle inhibition (AMI).[27] The reduction in ROM in our study population could be related to AMI. The improvements in ROM postintervention may be because of reduction in pain and muscle spasm indirectly reducing inhibition. Both PRICE protocol and exercise have proven effects on AMI; this explains no difference between the groups. PRICE protocol and exercises had similar effects on AMI, resulting in an equivalent increase in ROM in both the groups.

Function

There was a significant improvement in ankle function in both the groups; however, we could not demonstrate a significant change between them. The results can be attributed to the reason that in the short term, functional improvements may not be perceived as necessary by the patients, or recovery in function may require more time. Likely, the exercise may not ideally be applied during the acute phase of the rehabilitation. Wayne[26] suggested that exercise or any available treatment could be applied best after the acute effects have resolved and any functional residual may be more easily identified and addressed. Even if we could not report a difference in functional outcomes, we propose a longer follow-up, and testing at multiple time intervals would have shown a better insight into the findings.

Bleakley et al.[15] used a similar outcome measure and reported a significant improvement in LEFS scores between the ARG and the standard treatment group. In their study, they reported changes at different time intervals. Despite showing positive findings, they had many dropouts, specifically in the experimental group, which may have confounded their results. Brison et al.[8] did not find a difference in functional outcomes by adding a supervised treatment program to usual care. Their study compared a supervised intervention (designed according to goals) with usual care. Although our aims are not identical to their study, the UCG acted as a control, while the other group had a supervised treatment plan for 14 days. Our findings agreed to their reported results for functional improvements.

Strengths and limitations

This is the first randomized study to evaluate cryotherapy (ice) versus a no ice intervention to the best of our knowledge. The limitation of the study should be acknowledged in the interpretation of our findings. Being a pilot study, the sample size was small and did not have sufficient power to identify actual changes. The second limitation we grasped was a lack of multiple time measurements, which would have explained the findings more clearly. Finally, due to practice constraints patients coming to us at any time within the 72-h duration of the injury, were denoted as presenting on “day 1” was a potential limitation too.


  Conclusion Top


Interventions used in both the groups resulted in a significant reduction in pain 2 weeks postacute LAS. The two groups had similar pain, ROM, and ankle function improvements at the end of the study duration. The study could not demonstrate any difference between the two groups at the end of the treatment session.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
  References Top

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    Figures

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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5]



 

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